xml: <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/NCT05985811</url>
    </required_header>
    <id_info>
      <org_study_id>SalemAnes2018 Ketamine Mood</org_study_id>
      <nct_id>NCT05985811</nct_id>
    </id_info>
    <brief_title>Ketamine Enhances Analgesia and Mood in Chronic Pain Patients</brief_title>
    <official_title>Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Salem Anaesthesia Pain Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Salem Anaesthesia Pain Clinic</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Most chronic pain patients have mood disorders. The mood disorders may improve with better&#xD;
        analgesia produced by Ketamine injections. A prospective study of patients undergoing&#xD;
        interventional pain therapy using Ketamine injections. Pre-injection and post-injection&#xD;
        patient data is collected. Pain is measured using numeric pain rating scale, and change in&#xD;
        pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale,&#xD;
        and change in sleep score by 2-points is considered significant. Anxiety is measured using&#xD;
        general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered&#xD;
        significant. Depression is measured using patient health questionnaire (PHQ-9), and change in&#xD;
        depression score by 5-points is considered significant.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic pain is usually associated with psychological and mood disorders. Many chronic pain&#xD;
        patients have various forms of mood abnormalities; and these mood issues may improve with&#xD;
        better analgesia produced by Ketamine injections.&#xD;
  &#xD;
        This is a prospective observational study of consenting adult patients who are undergoing&#xD;
        interventional pain management. The patients undergo routine interventional pain therapy&#xD;
        using Ketamine injections. Pre-injection and post-injection patient data is collected using&#xD;
        validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score,&#xD;
        sleep score, anxiety score and depression score.&#xD;
  &#xD;
        Pain score is measured using the numeric pain rating scale, and a change in the pain score by&#xD;
        2-points is considered significant. Sleep score is measured using the Likert sleep scale, and&#xD;
        a change in the sleep score by 2-points is considered significant. Anxiety is measured using&#xD;
        the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is&#xD;
        considered significant. Depression is measured using the patient health questionnaire (PHQ-9)&#xD;
        scale, and a change in the depression score by 5-points is considered significant.&#xD;
  &#xD;
        Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson&#xD;
        Chi-square test, and regression analysis. P-value &lt;0.05 is considered significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 2, 2018</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pain score, objective measurement using the validated Numeric Pain Rating scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality score, objective measurement using the validated Likert sleep scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Mood Disorder; Opioid</condition>
    <condition>Mood Insomnia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult chronic pain clinic patients who have mood disorders; and undergoing routine regular&#xD;
          ketamine injections for pain therapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult chronic pain patients&#xD;
  &#xD;
            -  associated mood disorder&#xD;
  &#xD;
            -  good treatment compliance&#xD;
  &#xD;
            -  associated chronic insomnia&#xD;
  &#xD;
            -  regular ketamine pain therapy injection&#xD;
  &#xD;
            -  consent for clinical record quality assurance review&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe cognitive disorder&#xD;
  &#xD;
            -  inability to provide consent&#xD;
  &#xD;
            -  major neuropsychiatric disorder&#xD;
  &#xD;
            -  cannabis use&#xD;
  &#xD;
            -  stimulant use&#xD;
  &#xD;
            -  substance abuse&#xD;
  &#xD;
            -  poor treatment compliance&#xD;
  &#xD;
            -  lack of ketamine pain therapy injection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Olumuyiwa Bamgbade, MD,FRCPC</last_name>
      <role>Principal Investigator</role>
      <affiliation>Salem Anaesthesia Pain Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olumuyiwa Bamgbade, MD,FRCPC</last_name>
      <phone>17786286600</phone>
      <email>salem.painclinic@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Olu Bamgbade, MD,FRCPC</last_name>
      <phone>17786286600</phone>
      <email>olu.bamgbade@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Salem Anaesthesia Pain Clinic</name>
        <address>
          <city>Surrey</city>
          <state>British Columbia</state>
          <zip>V3S 7J1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Olumuyiwa Bamgbade, MD, FRCPC</last_name>
        <phone>+17786286600</phone>
        <email>salem.painclinic@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mood therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Mood Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985811
  org study id: SalemAnes2018 Ketamine Mood
  nct id: NCT05985811
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Most chronic pain patients have mood disorders. The mood disorders may improve with better
        analgesia produced by Ketamine injections. A prospective study of patients undergoing
        interventional pain therapy using Ketamine injections. Pre-injection and post-injection
        patient data is collected. Pain is measured using numeric pain rating scale, and change in
        pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale,
        and change in sleep score by 2-points is considered significant. Anxiety is measured using
        general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered
        significant. Depression is measured using patient health questionnaire (PHQ-9), and change in
        depression score by 5-points is considered significant.
  Chronic pain is usually associated with psychological and mood disorders. Many chronic pain
        patients have various forms of mood abnormalities; and these mood issues may improve with
        better analgesia produced by Ketamine injections.
  
        This is a prospective observational study of consenting adult patients who are undergoing
        interventional pain management. The patients undergo routine interventional pain therapy
        using Ketamine injections. Pre-injection and post-injection patient data is collected using
        validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score,
        sleep score, anxiety score and depression score.
  
        Pain score is measured using the numeric pain rating scale, and a change in the pain score by
        2-points is considered significant. Sleep score is measured using the Likert sleep scale, and
        a change in the sleep score by 2-points is considered significant. Anxiety is measured using
        the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is
        considered significant. Depression is measured using the patient health questionnaire (PHQ-9)
        scale, and a change in the depression score by 5-points is considered significant.
  
        Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson
        Chi-square test, and regression analysis. P-value <0.05 is considered significant.
  observational model: Cohort
  time perspective: Prospective
  measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
  time frame: 12 weeks
  description: Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
  measure: Sleep quality score, objective measurement using the validated Likert sleep scale
  time frame: 12 weeks
  description: Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Olumuyiwa Bamgbade, MD,FRCPC
  role: Principal Investigator
  affiliation: Salem Anaesthesia Pain Clinic
  last name: Olumuyiwa Bamgbade, MD,FRCPC
  phone: 17786286600
  email: salem.painclinic@gmail.com
  last name: Olu Bamgbade, MD,FRCPC
  phone: 17786286600
  email: olu.bamgbade@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Chronic Pain
  mesh term: Mood Disorders