<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421456</url>
  </required_header>
  <id_info>
    <org_study_id>GWAP19030</org_study_id>
    <secondary_id>2019-003369-16</secondary_id>
    <nct_id>NCT04421456</nct_id>
  </id_info>
  <brief_title>Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment</brief_title>
  <official_title>A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P&#xD;
      versus placebo in participants with schizophrenia experiencing inadequate response to ongoing&#xD;
      antipsychotic treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study was terminated based on a business decision by the Sponsor.&#xD;
  </why_stopped>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">March 16, 2022</completion_date>
  <primary_completion_date type="Actual">March 16, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score</measure>
    <time_frame>Baseline up to Week 12</time_frame>
    <description>The CGI-S is a 7-point scale used to rate the severity of participants' illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Body Weight</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Body Mass Index (BMI)</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Waist Circumference</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Blood Pressure</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Heart Rate</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Respiratory Rate</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Temperature</measure>
    <time_frame>Baseline up to Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results</measure>
    <time_frame>Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values</measure>
    <time_frame>Day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline (screening) up to Day 85</time_frame>
    <description>The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>GWP42003-P 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GWP42003-P 300 milligrams (mg) per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GWP42003-P 1000 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GWP42003-P 1000 mg per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GWP42003-P</intervention_name>
    <description>oral solution containing 100 milligrams per milliliter (mg/mL) cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol (10% v/v), with sweetener (sucralose), and strawberry flavoring</description>
    <arm_group_label>GWP42003-P 1000 mg</arm_group_label>
    <arm_group_label>GWP42003-P 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 to 55 years of age at the time of signing the Informed Consent Form&#xD;
             (ICF)&#xD;
&#xD;
          -  Willing and able to give informed consent for participation in the trial&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of&#xD;
             schizophrenia, confirmed by the Mini International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
          -  Clinically stable outpatient&#xD;
&#xD;
          -  Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) score of ≥ 60 and &lt; 110&#xD;
             at screening and baseline visits&#xD;
&#xD;
          -  Score of ≥ 4 for at least 2 of the following PANSS items: delusions (P1), conceptual&#xD;
             disorganization (P2), hallucinatory behavior (P3), suspiciousness (P6), somatic&#xD;
             concern (G1), or unusual thought content (G9) at screening visit&#xD;
&#xD;
          -  Score ≥ 4 (at least moderately ill) on the Clinical Global Impression of Severity&#xD;
             (CGI-S) at screening visit.&#xD;
&#xD;
          -  Undergoing treatment with at least 1 antipsychotic medication with no change in&#xD;
             dosing, supported by documentation, for at least 8 weeks prior to screening and no&#xD;
             change in antipsychotic medication dosing planned throughout the trial&#xD;
&#xD;
          -  Taking a maximum of 2 antipsychotic medications. For participants taking oral&#xD;
             antipsychotic medications only, the sum of primary and secondary antipsychotic&#xD;
             medications is ≤ 30 milligrams (mg)/day of oral olanzapine equivalents. For&#xD;
             participants taking long-acting injectable antipsychotic medications, the dose is&#xD;
             within the range approved and any secondary oral antipsychotic medications is ≤ 5&#xD;
             mg/day of oral olanzapine equivalents.&#xD;
&#xD;
          -  Documented response (at least partially) to treatment with current antipsychotic&#xD;
             medications (e.g., treatment of recent exacerbation of psychotic symptoms)&#xD;
&#xD;
          -  On a stable dose if taking concomitant psychotropic medications and within allowed&#xD;
             limits, including antidepressants, anxiolytics, anticholinergics and/or antiepileptics&#xD;
             for at least 4 weeks prior to screening (dose reductions ≤ 25% of total dose are&#xD;
             permitted) with no plans to change dosing during the trial (i.e., from screening&#xD;
             onwards). Valproic acid or any prescribed valproate product (valproate semisodium or&#xD;
             valproate sodium) is disallowed within 4 weeks (i.e., more than 5 half lives) prior to&#xD;
             the baseline visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diagnosis and Psychiatric History&#xD;
&#xD;
          -  Recent (within the last 3 months prior to screening) diagnosis of panic disorder,&#xD;
             depressive episode, or other comorbid psychiatric conditions based on the MINI for&#xD;
             Psychotic Disorders Studies (or DSM-5) OR has PANSS item G6 score of ≥ 5 (depression)&#xD;
             at screening.&#xD;
&#xD;
          -  Any psychiatric disorder that may interfere with the conduct of this trial, including&#xD;
             but not limited to attention deficit hyperactivity disorder, pervasive developmental&#xD;
             disorder, intellectual disability, personality disorder that might interfere with&#xD;
             compliance or increase suicidal risk, manic or hypomanic episode, or any other&#xD;
             psychotic disorder, as defined in the DSM-5&#xD;
&#xD;
          -  Current diagnosis or a history of substance use disorder according to DSM-5 criteria&#xD;
             within 6 months prior to screening or prior chronic substance abuse judged likely to&#xD;
             recur during the trial period by the investigator. Nicotine use or occasional cannabis&#xD;
             use (≤ 3 days per week recreational cannabis use) is acceptable. Corroboration of the&#xD;
             participant's frequency of cannabis use by an adult informant (e.g., family member,&#xD;
             social worker, caseworker, residential facility staff, or nurse), should be obtained&#xD;
             if the participant has a positive urine test for Δ9-tetrahydrocannabinol at screening.&#xD;
&#xD;
          -  A positive drug screen for opiates, methadone, cocaine, amphetamines (including&#xD;
             ecstasy), or barbiturates; a repeat drug screen may be done to verify the result.&#xD;
&#xD;
          -  Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the adult&#xD;
             C-SSRS or within 1 month prior to screening&#xD;
&#xD;
        Treatment History&#xD;
&#xD;
          -  Treatment-resistant schizophrenia as judged by the treating physician and as defined&#xD;
             by having previously demonstrated no response to &gt; 2 trials of antipsychotic trial&#xD;
             medications at therapeutic doses or required clozapine therapy due to non-response to&#xD;
             antipsychotic therapy within the previous 6 months.&#xD;
&#xD;
          -  Based on the investigator assessment, current antipsychotic medication blood levels&#xD;
             are below the therapeutic range if therapeutic drug monitoring is available for the&#xD;
             antipsychotic(s) prescribed for the participant; or there is no documentation&#xD;
             confirming the administration of long-acting injectable antipsychotic medication&#xD;
             within the approved dose range and as prescribed by the treating physician.&#xD;
&#xD;
        Past and Current Medical History&#xD;
&#xD;
          -  History of moderate or severe head trauma (for example, loss of consciousness for more&#xD;
             than 15 minutes) or other neurological disorders (including epilepsy),&#xD;
             neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple&#xD;
             sclerosis, Huntington's disease, etc.) or systemic medical diseases that are, in the&#xD;
             opinion of the investigator, likely to interfere with the conduct of the trial or&#xD;
             confound the trial assessments&#xD;
&#xD;
          -  Tardive dyskinesia (TD) that is moderate to severe (i.e., a score of &gt; 21 on the&#xD;
             dyskinesia subscale of the Extrapyramidal Symptom Rating Scale [ESRS] at screening) or&#xD;
             requires treatment&#xD;
&#xD;
          -  Any other significant disease, disorder, pending court proceedings or social&#xD;
             circumstances which, in the opinion of the investigator, may either put the&#xD;
             participant at risk because of participation in the trial, may influence the result of&#xD;
             the trial, or may affect the participant's ability to take part in the trial.&#xD;
&#xD;
        Other&#xD;
&#xD;
          -  Any known or suspected hypersensitivity to cannabinoids or any of the excipients of&#xD;
             the investigational medicinal product, such as sesame seed oil&#xD;
&#xD;
          -  One or more laboratory values outside the normal range, based on the blood or urine&#xD;
             samples taken at the screening visit, that are considered by the investigator to be&#xD;
             clinically significant; or impaired hepatic function at screening, defined as serum&#xD;
             alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 2 × upper limit&#xD;
             of normal (ULN) or total bilirubin (TBL) &gt; 1.5 × ULN or international normalized ratio&#xD;
             (INR) &gt; 1.2 (TBL ULN parameter not applicable for participants diagnosed with&#xD;
             Gilbert's disease)&#xD;
&#xD;
          -  Currently using or within 3 months of screening has used cannabidiol (CBD) oil or&#xD;
             purified CBD preparations and is unwilling to abstain for the duration of the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Bentonville</city>
        <state>Arkansas</state>
        <zip>72712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211-3702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94607-3900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90660-4920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Lincolnwood</city>
        <state>Illinois</state>
        <zip>60712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Cedarhurst</city>
        <state>New York</state>
        <zip>11516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Belchatow</city>
        <zip>97-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80-438</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kielce</city>
        <zip>25-411</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kobierzyce</city>
        <zip>55-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Torun</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-227</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>54-617</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#1</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#2</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#1</name>
      <address>
        <city>Kovin</city>
        <zip>26220</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#2</name>
      <address>
        <city>Kovin</city>
        <zip>26220</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#1</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#2</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site#3</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Nis</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Salamanca</city>
        <zip>37005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Valladolid</city>
        <zip>47016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>March 16, 2023</results_first_submitted>
  <results_first_submitted_qc>June 13, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 15, 2023</results_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GWP42003-P</keyword>
  <keyword>adjunctive therapy</keyword>
  <keyword>inadequate response to ongoing antipsychotic treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04421456/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 8, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04421456/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 95 participants who met all inclusion and no exclusion criteria were enrolled in the study and were randomized to the Placebo Run-in Period. Eighteen participants failed the Placebo Run-in Period. A total of 77 participants were randomized to 1 of 2 GWP42003-P doses or placebo treatment at a 2:2:1:1 ratio at 33 clinic centers.</recruitment_details>
      <pre_assignment_details>Once enrolled, participants were randomized to treatment following a single-blind, 2-week Placebo Run-in Period. A total of 95 participants were included the Placebo Run-in Period; 18 participants failed the Placebo Run-in Period. A total of 77 participants were randomized to the Treatment Period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GWP42003-P 300 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>GWP42003-P 1000 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Pooled Placebo</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomized Placebo Run-in Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Placebo Run-in Failures</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Randomized Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27">Of the 77 participants who completed the Placebo Run-in Period, 27 were randomized to GWP42003-P 300 mg.</participants>
                <participants group_id="P2" count="24">Of the 77 participants who completed the Placebo Run-in Period, 24 were randomized to GWP42003-P 1000 mg.</participants>
                <participants group_id="P3" count="26">Of the 77 participants who completed the Placebo Run-in Period, 26 were randomized to pooled placebo.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of parent/legal representative consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographics and baseline characteristics were assessed in the Full Analysis Set in the Treatment Period.</population>
      <group_list>
        <group group_id="B1">
          <title>GWP42003-P 300 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>GWP42003-P 1000 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Pooled Placebo</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="26"/>
            <count group_id="B4" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.5" spread="7.53"/>
                    <measurement group_id="B2" value="39.2" spread="8.21"/>
                    <measurement group_id="B3" value="38.7" spread="8.87"/>
                    <measurement group_id="B4" value="38.4" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score</title>
        <description>The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score</title>
          <description>The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
          <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.49" spread="1.64"/>
                    <measurement group_id="O2" value="-10.69" spread="1.75"/>
                    <measurement group_id="O3" value="-8.74" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.</non_inferiority_desc>
            <p_value>0.4528</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-1.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.35</ci_lower_limit>
            <ci_upper_limit>2.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.</non_inferiority_desc>
            <p_value>0.4226</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-1.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.76</ci_lower_limit>
            <ci_upper_limit>2.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score</title>
        <description>The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score</title>
          <description>The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
          <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.16" spread="0.59"/>
                    <measurement group_id="O2" value="-3.75" spread="0.63"/>
                    <measurement group_id="O3" value="-2.53" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.4479</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.83</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.25</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.1616</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-1.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.87</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.92</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score</title>
        <description>The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score</title>
          <description>The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
          <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.64" spread="0.53"/>
                    <measurement group_id="O2" value="-1.57" spread="0.56"/>
                    <measurement group_id="O3" value="-2.33" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.6787</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.80</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.3351</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>0.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.79</ci_lower_limit>
            <ci_upper_limit>2.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score</title>
        <description>The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score</title>
          <description>The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
          <population>Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.78" spread="1.03"/>
                    <measurement group_id="O2" value="-4.91" spread="1.10"/>
                    <measurement group_id="O3" value="-3.68" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.4504</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-1.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.96</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.4195</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>-1.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.22</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score</title>
        <description>The CGI-S is a 7-point scale used to rate the severity of participants' illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Efficacy outcomes were assessed in the Full Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score</title>
          <description>The CGI-S is a 7-point scale used to rate the severity of participants' illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.</description>
          <population>Efficacy outcomes were assessed in the Full Analysis Set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.47" spread="0.11"/>
                    <measurement group_id="O2" value="-0.50" spread="0.12"/>
                    <measurement group_id="O3" value="-0.45" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.8850</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.</non_inferiority_desc>
            <p_value>0.7808</p_value>
            <method>Mixed-effects repeated measures model</method>
            <param_type>Least square mean difference</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.36</ci_lower_limit>
            <ci_upper_limit>0.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12</title>
        <description>The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.</description>
        <time_frame>Week 12</time_frame>
        <population>Clinical Global Impression of Improvement (CGI-I) Score was assessed in the Full Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12</title>
          <description>The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.</description>
          <population>Clinical Global Impression of Improvement (CGI-I) Score was assessed in the Full Analysis Set in participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6707</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.412</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.288</ci_lower_limit>
            <ci_upper_limit>6.924</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4883</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.576</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.121</ci_lower_limit>
            <ci_upper_limit>2.744</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Body Weight</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Body weight was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Body Weight</title>
          <population>Body weight was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="3.09"/>
                    <measurement group_id="O2" value="-0.14" spread="1.98"/>
                    <measurement group_id="O3" value="1.37" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Body Mass Index (BMI)</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Body mass index was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Body Mass Index (BMI)</title>
          <population>Body mass index was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.98"/>
                    <measurement group_id="O2" value="-0.04" spread="0.66"/>
                    <measurement group_id="O3" value="0.45" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Waist Circumference</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Waist circumference was assessed in the Safety Analysis set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Waist Circumference</title>
          <population>Waist circumference was assessed in the Safety Analysis set in participants with available data.</population>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="5.36"/>
                    <measurement group_id="O2" value="-0.53" spread="2.07"/>
                    <measurement group_id="O3" value="1.34" spread="3.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Blood Pressure</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Blood pressure was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Blood Pressure</title>
          <population>Blood pressure was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="6.19"/>
                    <measurement group_id="O2" value="0" spread="7.05"/>
                    <measurement group_id="O3" value="-0.2" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="9.38"/>
                    <measurement group_id="O2" value="0" spread="8.41"/>
                    <measurement group_id="O3" value="0.3" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Heart Rate</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Heart rate was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Heart Rate</title>
          <population>Heart rate was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="8.46"/>
                    <measurement group_id="O2" value="-3.1" spread="9.13"/>
                    <measurement group_id="O3" value="0.1" spread="6.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Respiratory Rate</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Respiratory rate was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Respiratory Rate</title>
          <population>Respiratory rate was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>breaths/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="2.13"/>
                    <measurement group_id="O2" value="0.1" spread="1.37"/>
                    <measurement group_id="O3" value="0" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Temperature</title>
        <time_frame>Baseline up to Week 12</time_frame>
        <population>Temperature was assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Temperature</title>
          <population>Temperature was assessed in the Safety Analysis Set in participants with available data.</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.34"/>
                    <measurement group_id="O2" value="0.06" spread="0.20"/>
                    <measurement group_id="O3" value="-0.02" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results</title>
        <time_frame>Day 85</time_frame>
        <population>Clinically significant changes from baseline in vital signs were assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results</title>
          <population>Clinically significant changes from baseline in vital signs were assessed in the Safety Analysis Set in participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine systolic blood pressure, Day 85: &lt;-20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine systolic blood pressure, Day 85: &gt;20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine diastolic blood pressure, Day 85: &lt;-10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine diastolic blood pressure, Day 85: &gt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate, Day 85: &lt;-20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart rate, Day 85: &gt;20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight, Day 85: ≤-7%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight, Day 85: ≥7%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values</title>
        <time_frame>Day 85</time_frame>
        <population>Defined flagged ECG values were assessed in the Safety Analysis Set in participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values</title>
          <population>Defined flagged ECG values were assessed in the Safety Analysis Set in participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QTcF interval, Day 85: &gt;450 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval, Day 85: &gt;480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF interval, Day 85: &gt;500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.</description>
        <time_frame>Baseline (screening) up to Day 85</time_frame>
        <population>Suicidal ideation and behavior was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>GWP42003-P 300 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>GWP42003-P 1000 mg</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Placebo</title>
            <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.</description>
          <population>Suicidal ideation and behavior was assessed in the Safety Analysis Set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening, Suicidal ideation, Wish to be dead</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal ideation, Non-specific active suicidal thoughts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal ideation, Active with any methods (not planned) without intent to act</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal ideation, Active with some intent to act, without specific plan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal ideation, Active with specific plan and intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal behavior, Preparatory acts or behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal behavior, Aborted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal behavior, Interrupted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal behavior, Actual attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screening, Suicidal behavior, Completed suicide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal ideation, Wish to be dead</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal ideation, Non-specific active suicidal thoughts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal ideation, Active with any methods (not planned) without intent to act</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal ideation, Active with some intent to act, without specific plan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal ideation, Active with specific plan and intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal behavior, Preparatory acts or behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal behavior, Aborted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal behavior, Interrupted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal behavior, Actual attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Suicidal behavior, Completed suicide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal ideation, Wish to be dead</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal ideation, Non-specific active suicidal thoughts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal ideation, Active with any methods (not planned) without intent to act</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal ideation, Active with some intent to act, without specific plan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal ideation, Active with specific plan and intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal behavior, Preparatory acts or behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal behavior, Aborted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal behavior, Interrupted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal behavior, Actual attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, Suicidal behavior, Completed suicide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal ideation, Wish to be dead</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal ideation, Non-specific active suicidal thoughts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal ideation, Active with any methods (not planned) without intent to act</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal ideation, Active with some intent to act, without specific plan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal ideation, Active with specific plan and intent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal behavior, Preparatory acts or behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal behavior, Aborted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal behavior, Interrupted attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal behavior, Actual attempt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85, Suicidal behavior, Completed suicide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GWP42003-P 300 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>GWP42003-P 1000 mg</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Pooled Placebo (Treatment Period)</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Pooled Placebo (Placebo Run-In Period)</title>
          <description>Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo for 2 weeks (including participants who failed the placebo-run in period).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>Coronavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure &amp; Transparency</name_or_title>
      <organization>Jazz Pharmaceuticals</organization>
      <phone>215-832-3750</phone>
      <email>ClinicalTrialDisclosure@JazzPharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421456
org study id: GWAP19030
secondary id: 2019-003369-16
nct id: NCT04421456
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P
      versus placebo in participants with schizophrenia experiencing inadequate response to ongoing
      antipsychotic treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score
time frame: Baseline up to Week 12
description: The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
measure: Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score
time frame: Baseline up to Week 12
description: The PANSS 'P' Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
measure: Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score
time frame: Baseline up to Week 12
description: The PANSS 'N' Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
measure: Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score
time frame: Baseline up to Week 12
description: The PANSS 'G' Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
measure: Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score
time frame: Baseline up to Week 12
description: The CGI-S is a 7-point scale used to rate the severity of participants' illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
measure: Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12
time frame: Week 12
description: The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.
measure: Mean Change From Baseline in Body Weight
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Body Mass Index (BMI)
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Waist Circumference
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Blood Pressure
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Heart Rate
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Respiratory Rate
time frame: Baseline up to Week 12
measure: Mean Change From Baseline in Temperature
time frame: Baseline up to Week 12
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results
time frame: Day 85
measure: Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values
time frame: Day 85
measure: Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline (screening) up to Day 85
description: The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.
arm group label: GWP42003-P 300 mg
arm group type: Experimental
description: GWP42003-P 300 milligrams (mg) per day
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo
arm group label: GWP42003-P 1000 mg
arm group type: Experimental
description: GWP42003-P 1000 mg per day
intervention type: Drug
intervention name: GWP42003-P
description: oral solution containing 100 milligrams per milliliter (mg/mL) cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol (10% v/v), with sweetener (sucralose), and strawberry flavoring
arm group label: GWP42003-P 1000 mg
arm group label: GWP42003-P 300 mg
intervention type: Drug
intervention name: Placebo
description: oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
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country: Poland
country: Serbia
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No
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