<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/NCT03830827</url>
  </required_header>
  <id_info>
    <org_study_id>S2018008</org_study_id>
    <nct_id>NCT03830827</nct_id>
  </id_info>
  <brief_title>MBRP + Vortioxetine VS MBRP on Preventing Relapse in Chronic MA Users</brief_title>
  <official_title>Efficacy of Mindfulness-based Relapse Prevention With or Without Vortioxetine on the Prevention of Relapse in Chronic Methamphetamine Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shenzhen Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sir Run Run Shaw Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 multicenter, double-blind, Randomized, parallel-group study in subjects with&#xD;
      methamphetamine dependence was to assess the efficacy of MBRP combined with vortioxetine and&#xD;
      MBRP alone on 24-week abstinence rates, improvement of cognition and depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who allocate to the experimental group will receive 8-week 10-20mg/day&#xD;
      vortioxetine combined with MBRP intervention. Participants who allocate to the control group&#xD;
      will receive 8-week 1-2#/day placebo combined with MBRP intervention.&#xD;
&#xD;
      Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major&#xD;
      depressive disorder, has been approved by the Chinese Food and Drug Administration in the use&#xD;
      of China in 2018.&#xD;
&#xD;
      The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group&#xD;
      format (10-14 participants) by two therapists to prevent MA relapse. In MBRP, therapists&#xD;
      facilitate discussions and exercises and introduce the meditation practice component. Group&#xD;
      sessions include discussions of mindfulness as a means of coping with MA craving, negative&#xD;
      affect and painful cognitions/sensations that precipitate relapse, role-playing exercises,&#xD;
      meditation practice and implement practice into high-risk situations and in daily life, as&#xD;
      well as homework assignments.&#xD;
&#xD;
      Participants from both groups will also receive 10 visits: visit 1 (week 0): medical and&#xD;
      psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and&#xD;
      cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse&#xD;
      rates), assessment of depressive symptoms, improvement in cognition and MA craving.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Timeline Followback (TLFB) for MA relapse rates</measure>
    <time_frame>24 weeks</time_frame>
    <description>The primary objective is Methamphetamine (MA) relapse rates will be assessed by the Timeline Follow Back (TFB) at weeks 1, 2, 3, 4, 5, 6, 7, 8, and 24. TLFB is a technique for assessing self-reported alcohol or drug consumption that can be used as a clinical and research tool to obtain a variety of quantitative estimates of MA use. This outcome measure integrates data from self-reported supplied in the Time Line Follow Back (a self-reported summary of all substance use over the previous week) with biological verification.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)</measure>
    <time_frame>24 weeks</time_frame>
    <description>The efficacy of intervention for depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 2) to Week 24 (Visit 10). MADRS is a 10-item rating scale designed to measure overall severity of the symptoms in depressive and to be sensitive to treatment effects. Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom) with an overall score range from 0 to 60. Participants were considered responsive to vortioxetine if their MADRS score decreased by 50% or more from baseline to the end of treatment，and to be in remission if their final MADRS score is less than 10. A higher score indicates a more severe symptom, and a lower score from the baseline indicates an improvement in symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition function will be assessed by THINC-it® cognition screening tool</measure>
    <time_frame>24 weeks</time_frame>
    <description>THINC-it® is a sensitive cognitive screening tool for measuring the change of cognitive function and determining whether cognitive function is impaired. It required approximately 10 to 15 minutes for administration. It includes variants of the Choice Reaction Time Identification Task (IDN), One-Back Test, Digit Symbol Substitution Test, Trail Making Test-Part B, and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Relapse</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>MBRP+vortioxetine intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.&#xD;
10-20mg/day vortioxetine will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBRP intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.&#xD;
1-2#/day placebo will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks</description>
    <arm_group_label>MBRP intervention</arm_group_label>
    <arm_group_label>MBRP+vortioxetine intervention</arm_group_label>
    <other_name>Mindfulness-based relapse prevention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. DSM-V diagnosis of MA dependence within the last year&#xD;
&#xD;
          2. completion or scheduled completion (i.e., within 2 weeks) of inpatient or intensive&#xD;
             outpatient treatment for MA dependence.&#xD;
&#xD;
          3. express a wish to remain abstinent from MA use&#xD;
&#xD;
          4. be age 18 to 65&#xD;
&#xD;
          5. be fluent in speaking Mandarin and literate in Chinese and able to read, understand,&#xD;
             and complete the rating scales and questionnaires accurately, follow instructions, and&#xD;
             make use of mindfulness techniques&#xD;
&#xD;
          6. willingness to randomization and attendance at treatment and assessment sessions&#xD;
&#xD;
          7. be able to attend all clinic visits without interruption&#xD;
&#xD;
          8. score greater than 16 on the HAM D17 and MADRS &gt;= 26, as well as currently not on any&#xD;
             psychotropics for treatment of depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any current Axis I DSM-V psychiatric disorder other than MA or nicotine dependence&#xD;
             that, in the clinician's opinion, warrants treatment or would preclude safe&#xD;
             participation in the protocol, including, but not limited to: psychosis,&#xD;
             schizophrenia, dementia, schizotypal personality disorder, borderline personality&#xD;
             disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic&#xD;
             suicidality or homicidality, mental retardation et al.&#xD;
&#xD;
          2. Serious medical comorbidity requiring medical intervention or close supervision,&#xD;
             including pacemakers, heart transplant, severe arrhythmias, or active atrial&#xD;
             fibrillation, gross neurological disease&#xD;
&#xD;
          3. Suicide attempt in the last 3 months&#xD;
&#xD;
          4. Pregnant or breastfeeding women&#xD;
&#xD;
          5. Prior treatment with vortioxetine or already participated in the MBRP program&#xD;
&#xD;
          6. Fail to provide informed consent&#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>Yanhui Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhenzhen Wu, MD</last_name>
    <phone>+8618865477115</phone>
    <email>zhenzhenjw@163.com</email>
  </overall_contact>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
    <investigator_full_name>Yanhui Liao</investigator_full_name>
    <investigator_title>Attending Psychiatrist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vortioxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03830827
org study id: S2018008
nct id: NCT03830827
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This multicenter, double-blind, Randomized, parallel-group study in subjects with
      methamphetamine dependence was to assess the efficacy of MBRP combined with vortioxetine and
      MBRP alone on 24-week abstinence rates, improvement of cognition and depressive symptoms.
Participants who allocate to the experimental group will receive 8-week 10-20mg/day
      vortioxetine combined with MBRP intervention. Participants who allocate to the control group
      will receive 8-week 1-2#/day placebo combined with MBRP intervention.

      Vortioxetine (Brintellix®), a novel antidepressant for the treatment of adult with major
      depressive disorder, has been approved by the Chinese Food and Drug Administration in the use
      of China in 2018.

      The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group
      format (10-14 participants) by two therapists to prevent MA relapse. In MBRP, therapists
      facilitate discussions and exercises and introduce the meditation practice component. Group
      sessions include discussions of mindfulness as a means of coping with MA craving, negative
      affect and painful cognitions/sensations that precipitate relapse, role-playing exercises,
      meditation practice and implement practice into high-risk situations and in daily life, as
      well as homework assignments.

      Participants from both groups will also receive 10 visits: visit 1 (week 0): medical and
      psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and
      cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse
      rates), assessment of depressive symptoms, improvement in cognition and MA craving.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The Timeline Followback (TLFB) for MA relapse rates
time frame: 24 weeks
description: The primary objective is Methamphetamine (MA) relapse rates will be assessed by the Timeline Follow Back (TFB) at weeks 1, 2, 3, 4, 5, 6, 7, 8, and 24. TLFB is a technique for assessing self-reported alcohol or drug consumption that can be used as a clinical and research tool to obtain a variety of quantitative estimates of MA use. This outcome measure integrates data from self-reported supplied in the Time Line Follow Back (a self-reported summary of all substance use over the previous week) with biological verification.
measure: Depressive symptoms will be assessed by Montgomery and Asberg Depression Rating Scale (MADRS, Chinese version)
time frame: 24 weeks
description: The efficacy of intervention for depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 2) to Week 24 (Visit 10). MADRS is a 10-item rating scale designed to measure overall severity of the symptoms in depressive and to be sensitive to treatment effects. Symptoms are rated on a 7-point Likert scale from 0 (no symptom) to 6 (severe symptom) with an overall score range from 0 to 60. Participants were considered responsive to vortioxetine if their MADRS score decreased by 50% or more from baseline to the end of treatment，and to be in remission if their final MADRS score is less than 10. A higher score indicates a more severe symptom, and a lower score from the baseline indicates an improvement in symptoms.
measure: Cognition function will be assessed by THINC-it® cognition screening tool
time frame: 24 weeks
description: THINC-it® is a sensitive cognitive screening tool for measuring the change of cognitive function and determining whether cognitive function is impaired. It required approximately 10 to 15 minutes for administration. It includes variants of the Choice Reaction Time Identification Task (IDN), One-Back Test, Digit Symbol Substitution Test, Trail Making Test-Part B, and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).
arm group label: MBRP+vortioxetine intervention
arm group type: Experimental
description: Participants who allocate to the experimental group will receive 8-week 10-20mg/day vortioxetine combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
10-20mg/day vortioxetine will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
arm group label: MBRP intervention
arm group type: Experimental
description: Participants who allocate to the control group will receive 8-week 1-2#/day placebo combined with MBRP intervention.The MBRP intervention is composed of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists to prevent MA relapse.
1-2#/day placebo will sent every day and 2-hour MBRP intervention per week until the end of 8-week intervention . They will also receive 10 visits: visit 1 (week 0): medical and psychiatric screening; visit 2-9 (week 1, 2, 3, 4, 5, 6, 7 and 8): depressive symptoms and cognitive function, MA use, and MA craving; visit 10 (week 24): MA use (assessment of relapse rates), assessment of depressive symptoms, improvement in cognition and MA craving.
intervention type: Drug
intervention name: Vortioxetine
description: 8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks
arm group label: MBRP intervention
arm group label: MBRP+vortioxetine intervention
other name: Mindfulness-based relapse prevention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanhui Liao, MD
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital
last name: Zhenzhen Wu, MD
phone: +8618865477115
email: zhenzhenjw@163.com
responsible party type: Principal Investigator
investigator affiliation: Sir Run Run Shaw Hospital
investigator full name: Yanhui Liao
investigator title: Attending Psychiatrist
mesh term: Recurrence
mesh term: Vortioxetine
sharing ipd: Undecided