<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/NCT04448808</url>
  </required_header>
  <id_info>
    <org_study_id>THC-PTBS</org_study_id>
    <nct_id>NCT04448808</nct_id>
  </id_info>
  <brief_title>Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol</brief_title>
  <official_title>Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol: A Randomized Controlled Study (THC PTSD-trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bionorica SE</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled exploratory phase II trial will test the hypothesis that oral&#xD;
      dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes)&#xD;
      to a greater extent than placebo over a ten week intervention phase in a parallel group&#xD;
      design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>
    <intervention_model_description>Randomized controlled study (double-blind)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency and intensity of nightmares</measure>
    <time_frame>10 weeks</time_frame>
    <description>Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the frequency and intensity of nightmares</measure>
    <time_frame>1, 2, 3, 4,6 and 8 weeks</time_frame>
    <description>Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the CAPS-5 total score</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Montgomery-Åsberg Depression Rating Scale</measure>
    <time_frame>4 and 10 weeks</time_frame>
    <description>Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of daily total sleep time</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of the patients sleep onset latency at night</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of the patients recuperation of night sleep</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of the patients time awake at night</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of the patients number of nightmares last night</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly mean of change from baseline of the patients intensity of nightmares</measure>
    <time_frame>during 10 weeks</time_frame>
    <description>Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Borderline Symptom List 23</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the Borderline Symptom List 23 (BSL-23) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Health-Related Quality of Life</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the Health-Related Quality of Life (EQ-5D) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patients status measured by the Patient Global Impression of Change</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Overall patients status measured by the Patient Global Impression of Change (PGIC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Social and Occupational Functioning Assessment Scale</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of the Pittsburgh Sleep Quality Index</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire</measure>
    <time_frame>6 and 10 weeks</time_frame>
    <description>Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist</measure>
    <time_frame>6 and 10 weeks and Follow- Up Visit 9</time_frame>
    <description>Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder analysis: proportion of patients showing improvement in nightmares</measure>
    <time_frame>10 weeks</time_frame>
    <description>Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 ≥50% assessed at the end of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remitter analysis: proportion of patients showing full remission of nightmares</measure>
    <time_frame>10 weeks</time_frame>
    <description>Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>BX-1 (dronabinol)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BX-1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo of BX-1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BX-1</intervention_name>
    <description>BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.</description>
    <arm_group_label>BX-1 (dronabinol)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo of BX-1, oral solution</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of posttraumatic stress disorder (PTSD) according to DSM 5 with a 20 item&#xD;
             CAPS-5 total score ≥ 26&#xD;
&#xD;
          2. At least two nightmares a week, an intensity score ≥ 2, with a CAPS-IV B2 (frequency&#xD;
             and intensity for the last week) score ≥ 5&#xD;
&#xD;
          3. Men and women between 18 and 65 years of age&#xD;
&#xD;
          4. Written informed consent&#xD;
&#xD;
          5. The patient has the capacity to give consent (He/she is able to understand the nature&#xD;
             and anticipated effects/side effects of the proposed medical intervention)&#xD;
&#xD;
          6. The patient is not breastfeeding&#xD;
&#xD;
          7. Women of child-bearing potential must have a negative urine or serum pregnancy test&#xD;
&#xD;
          8. All participants must use highly effective contraception&#xD;
&#xD;
          9. The patient received stable pharmacological medication for at least 4 weeks prior to&#xD;
             study entry (any changes in medication dose or frequency of therapy must be answered&#xD;
             with no)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime cannabis use disorder&#xD;
&#xD;
          2. Current substance/alcohol use disorder (≤ 3 months);&#xD;
&#xD;
          3. Acute suicidality;&#xD;
&#xD;
          4. Psychotic disorder;&#xD;
&#xD;
          5. Bipolar disorder;&#xD;
&#xD;
          6. Current anorexia nervosa;&#xD;
&#xD;
          7. Current major depressive episodes and a MADRS score &gt; 29;&#xD;
&#xD;
          8. Dementia;&#xD;
&#xD;
          9. Trauma-focused psychotherapy four weeks before the trial&#xD;
&#xD;
         10. Initiation of sleep medication 4 weeks prior screening or initiation of alpha&#xD;
             adrenergic agents 4 weeks prior to screening&#xD;
&#xD;
         11. Acute or unstable medical illness.&#xD;
&#xD;
         12. Epilepsy&#xD;
&#xD;
         13. Relevant heart diseases&#xD;
&#xD;
         14. Known HIV- and/or active Hepatitis-B- or Hepatitis-C-infection&#xD;
&#xD;
         15. Current or past malignant illness&#xD;
&#xD;
         16. The patient is unwilling to consent to saving, processing and propagation of&#xD;
             pseudonymized medical data for study reasons&#xD;
&#xD;
         17. Patients, who may be dependent on the sponsor, the investigator or the trial sites,&#xD;
             have to be excluded from the trial&#xD;
&#xD;
         18. The patient is legally detained in an official institution&#xD;
&#xD;
         19. The patient does have a known allergy or contraindication against Dronabinol&#xD;
&#xD;
         20. The patient does have clinically significant abnormalities in 12-lead ECG&#xD;
&#xD;
         21. The patient does have clinically significant laboratory abnormalities&#xD;
&#xD;
         22. The patient did participate in other interventional trials during the 3 months before&#xD;
             and at the time of this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Roepke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefan Roepke, MD</last_name>
    <phone>004930450517545</phone>
    <email>stefan.roepke@charite.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Berlin St. Hedwig</name>
      <address>
        <city>Berlin</city>
        <zip>10115</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nikola Schoofs</last_name>
      <email>nikola.schoofs@charite.de</email>
    </contact>
    <investigator>
      <last_name>Nikola Schoofs</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Psychiatrie und Psychotherapie</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Roepke</last_name>
      <phone>004930450517545</phone>
      <email>stefan.roepke@charite.de</email>
    </contact>
    <investigator>
      <last_name>Stefan Roepke</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zentralinstitut für Seelische Gesundheit Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>86159</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Stefan Roepke</investigator_full_name>
    <investigator_title>Prof. Dr. Stefan Roepke, MD</investigator_title>
  </responsible_party>
  <keyword>Nightmares</keyword>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>Dronabinol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04448808
org study id: THC-PTBS
nct id: NCT04448808
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled exploratory phase II trial will test the hypothesis that oral
      dronabinol improves nightmares (primary outcome) and other PTSD symptoms (secondary outcomes)
      to a greater extent than placebo over a ten week intervention phase in a parallel group
      design.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study (double-blind)
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency and intensity of nightmares
time frame: 10 weeks
description: Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.
measure: Change from baseline of the frequency and intensity of nightmares
time frame: 1, 2, 3, 4,6 and 8 weeks
description: Change from baseline of the frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8.
measure: Change from baseline of the CAPS-5 total score
time frame: 6 and 10 weeks
description: Change from baseline of the CAPS-5 total score (overall PTSD symptoms, last week)
measure: Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD
time frame: 6 and 10 weeks
description: Change from baseline of the Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI A) (PTSD related sleep symptoms)
measure: Change from baseline of the Montgomery-Åsberg Depression Rating Scale
time frame: 4 and 10 weeks
description: Change from baseline of the Montgomery-Åsberg Depression Rating Scale (MADRS, depressive symptoms)
measure: Weekly mean of change from baseline of daily total sleep time
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients daily total sleep time (in minutes), assessed with sleep diaries
measure: Weekly mean of change from baseline of the patients sleep onset latency at night
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients sleep onset latency at night (in minutes), assessed with sleep diaries
measure: Weekly mean of change from baseline of the patients recuperation of night sleep
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients recuperation of night sleep (5-point Likert scale, 1 = very much; 5 = not at all), assessed with sleep diaries
measure: Weekly mean of change from baseline of the patients time awake at night
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients time awake at night (in minutes), assessed with sleep diaries
measure: Weekly mean of change from baseline of the patients number of nightmares last night
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients number of nightmares last night (0, 1, 3, 4 or more) assessed with sleep diaries
measure: Weekly mean of change from baseline of the patients intensity of nightmares
time frame: during 10 weeks
description: Weekly mean of change from baseline of the patients intensity of nightmares (5-point Likert scale, 0 = not at all; 5 = extreme) assessed with sleep diaries
measure: Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5
time frame: 6 and 10 weeks
description: Change from baseline of PTSD symptoms assessed with the PTSD Checklist for DSM-5 (PCL-5)
measure: Change from baseline of the Borderline Symptom List 23
time frame: 6 and 10 weeks
description: Change from baseline of the Borderline Symptom List 23 (BSL-23) score
measure: Change from baseline of the Health-Related Quality of Life
time frame: 6 and 10 weeks
description: Change from baseline of the Health-Related Quality of Life (EQ-5D) score
measure: Overall patients status measured by the Patient Global Impression of Change
time frame: 6 and 10 weeks
description: Overall patients status measured by the Patient Global Impression of Change (PGIC)
measure: Change from baseline of the Social and Occupational Functioning Assessment Scale
time frame: 6 and 10 weeks
description: Change from baseline of the Social and Occupational Functioning Assessment Scale (SOFAS)
measure: Change from baseline of the Pittsburgh Sleep Quality Index
time frame: 6 and 10 weeks
description: Change from baseline of the Pittsburgh Sleep Quality Index (PSQI)
measure: Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire
time frame: 6 and 10 weeks
description: Change from baseline of symptoms of PTSD and complex PTSD according to ICD-11 assessed with the International Trauma Questionnaire (ITQ)
measure: Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist
time frame: 6 and 10 weeks and Follow- Up Visit 9
description: Change from baseline of THC withdraw symptoms assessed with the Marijuana Withdrawal Checklist (MWC)
measure: Responder analysis: proportion of patients showing improvement in nightmares
time frame: 10 weeks
description: Responder analysis: proportion of patients showing improvement in nightmares (change from baseline) defined as decrease of CAPS-IV B2 ≥50% assessed at the end of treatment
measure: Remitter analysis: proportion of patients showing full remission of nightmares
time frame: 10 weeks
description: Remitter analysis: proportion of patients showing full remission of nightmares defined as CAPS-IV B2 = 0, assessed at the end of treatment
arm group label: BX-1 (dronabinol)
arm group type: Experimental
description: BX-1
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo of BX-1
intervention type: Drug
intervention name: BX-1
description: BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
arm group label: BX-1 (dronabinol)
intervention type: Drug
intervention name: Placebo
description: Placebo of BX-1, oral solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stefan Roepke, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Stefan Roepke, MD
phone: 004930450517545
email: stefan.roepke@charite.de
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Stefan Roepke
investigator title: Prof. Dr. Stefan Roepke, MD
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No