<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/NCT01671436</url>
  </required_header>
  <id_info>
    <org_study_id>CMIT-1042</org_study_id>
    <nct_id>NCT01671436</nct_id>
  </id_info>
  <brief_title>Meditation for Depression</brief_title>
  <acronym>CMIT</acronym>
  <official_title>Central Meditation and Imagery Therapy for Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However,&#xD;
      currently available treatment options have limited efficacy. The aim of this pilot study is&#xD;
      to determine whether patients suffering from MDD who have not responded to at least one&#xD;
      antidepressant trial may actively engage in a novel group therapy, Central Meditation and&#xD;
      Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT&#xD;
      techniques may have benefit for major depression. The purpose of this trial is to assess the&#xD;
      feasibility of a group form of CMIT for the treatment of major depression. The trial will&#xD;
      also seek to identify neurophysiological and cardiovascular predictors of treatment response.&#xD;
&#xD;
      In this study, 10 subjects with major depressive disorder will receive antidepressant&#xD;
      treatment augmentation with group meditation and mental imagery therapy for a total of 12&#xD;
      weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic&#xD;
      stretches. The subjects will be limited to those who remain depressed despite at least one&#xD;
      trial of antidepressant medication. Changes in brain activity and heart rate variability will&#xD;
      be measured at three time points utilizing electroencephalography (EEG) and pulse monitors.&#xD;
      Depression symptoms will be measured at several time points using questionnaires and&#xD;
      objective measures. Participation will require a total of 15 visits for weekly therapy and&#xD;
      the measurements. Two-month follow-up questionnaires will be mailed to the subjects after&#xD;
      study end to assess durability of any improvements in depressive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Rating Scale for Depression (HAM-D)</measure>
    <time_frame>Measured 4 times over 12 weeks</time_frame>
    <description>Primary outcome is change in HAM-D from baseline to Week 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR)</measure>
    <time_frame>Weekly assessments measured over 12 weeks, and 2 month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Central Meditation and Imagery Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention involved Central Meditation, may be characterized by a voluntary, regulated attentional set towards a specific stimulus or set of stimuli and visualization exercises utilized within CMIT, which primarily involves two types of thought experiments: 1) creating mental models of how a person fits into the larger world and universe according to evolutionary biology and modern cosmology, in order to gain a larger perspective on emotions and thought patterns, and 2) backcasting, the generation of a desirable future coupled with mental time travel back to the present to determine how to create that future with present-day actions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Central Meditation and Imagery Therapy</intervention_name>
    <arm_group_label>Central Meditation and Imagery Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meeting the DSM-IV criteria for unipolar major depressive disorder, as assessed by the&#xD;
             Mini-Neuropsychiatric International Interview (MINI).&#xD;
&#xD;
          -  HAM-D17 rating scale ≥ 14.&#xD;
&#xD;
          -  Prior treatment with antidepressant medication during the present major depressive&#xD;
             episode&#xD;
&#xD;
          -  Adequate written and oral fluency in English to understand and complete study forms&#xD;
             and converse with study personnel.&#xD;
&#xD;
          -  Willingness on part of both subject and treating clinician to not change&#xD;
             antidepressant treatment, including medications, psychotherapy or other treatments,&#xD;
             over the course of the study, unless necessary to provide for well being of subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of schizophrenia or any psychotic disorder including psychotic&#xD;
             depression, dysthymia, mania or bipolar disorder, attention deficit or hyperactivity&#xD;
             disorder, generalized anxiety disorder or panic disorder, obsessive compulsive&#xD;
             disorder, alcohol or drug dependence, mental retardation, any pervasive developmental&#xD;
             disorder or cognitive disorder (according to DSM-IV) criteria. Those with lifetime&#xD;
             history of psychiatric conditions other than unipolar major depression will be also&#xD;
             excluded.&#xD;
&#xD;
          -  Medically unstable, delirious, or terminally ill (e.g. medical illness requiring&#xD;
             hospitalization or intense outpatient management, such as heart disease; heart attack&#xD;
             in the past 6 months; congestive heart failure; severe heart arrythmias; unstable&#xD;
             hypertension; poorly controlled diabetes; or pending surgery).&#xD;
&#xD;
          -  Past history of skull fracture; cranial surgery entering the calvarium; space&#xD;
             occupying intracranial lesion; stroke/ aneurysm; Parkinson's or Huntington's disease;&#xD;
             or Multiple Sclerosis.&#xD;
&#xD;
          -  Participants regularly practicing (≥ 2 times per week) any of the techniques utilized&#xD;
             in the study to reduce stress: meditation, guided imagery, yoga.&#xD;
&#xD;
          -  Current treatment with behavior therapy or psychotherapy.&#xD;
&#xD;
          -  Active suicidal plan as measured by HAM-D item 3 score of greater than or equal to 3,&#xD;
             or history of suicide attempt during the current episode.&#xD;
&#xD;
          -  Utilization of cannabis or other illicit drugs more than once a month.&#xD;
&#xD;
          -  Excessive use of alcohol, i.e., men whose alcohol consumption exceeds 14 standard&#xD;
             drinks per week or 4 drinks per day, and women whose alcohol consumption exceeds 7&#xD;
             standard drinks per week or 3 drinks per day.&#xD;
&#xD;
          -  Needing to adjust or change anti-depressant treatment, including medications,&#xD;
             psychotherapy, repetitive Transcranial Magnetic Stimulation (rTMS), Electroconvulsive&#xD;
             Therapy (ECT), or Vagus Nerve Stimulation (VNS).&#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>Felipe Jain, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Semel Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>January 11, 2021</last_update_submitted>
  <last_update_submitted_qc>January 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Guided Imagery</keyword>
  <keyword>Psychotherapy</keyword>
  <keyword>Meditation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671436
org study id: CMIT-1042
nct id: NCT01671436
lead sponsor: 
has dmc: Yes
Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However,
      currently available treatment options have limited efficacy. The aim of this pilot study is
      to determine whether patients suffering from MDD who have not responded to at least one
      antidepressant trial may actively engage in a novel group therapy, Central Meditation and
      Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT
      techniques may have benefit for major depression. The purpose of this trial is to assess the
      feasibility of a group form of CMIT for the treatment of major depression. The trial will
      also seek to identify neurophysiological and cardiovascular predictors of treatment response.

      In this study, 10 subjects with major depressive disorder will receive antidepressant
      treatment augmentation with group meditation and mental imagery therapy for a total of 12
      weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic
      stretches. The subjects will be limited to those who remain depressed despite at least one
      trial of antidepressant medication. Changes in brain activity and heart rate variability will
      be measured at three time points utilizing electroencephalography (EEG) and pulse monitors.
      Depression symptoms will be measured at several time points using questionnaires and
      objective measures. Participation will require a total of 15 visits for weekly therapy and
      the measurements. Two-month follow-up questionnaires will be mailed to the subjects after
      study end to assess durability of any improvements in depressive symptoms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hamilton Rating Scale for Depression (HAM-D)
time frame: Measured 4 times over 12 weeks
description: Primary outcome is change in HAM-D from baseline to Week 12.
measure: Quick Inventory of Depressive Symptoms- Self Report (QIDS- SR)
time frame: Weekly assessments measured over 12 weeks, and 2 month follow-up
arm group label: Central Meditation and Imagery Therapy
arm group type: Experimental
description: Intervention involved Central Meditation, may be characterized by a voluntary, regulated attentional set towards a specific stimulus or set of stimuli and visualization exercises utilized within CMIT, which primarily involves two types of thought experiments: 1) creating mental models of how a person fits into the larger world and universe according to evolutionary biology and modern cosmology, in order to gain a larger perspective on emotions and thought patterns, and 2) backcasting, the generation of a desirable future coupled with mental time travel back to the present to determine how to create that future with present-day actions.
intervention type: Behavioral
intervention name: Central Meditation and Imagery Therapy
arm group label: Central Meditation and Imagery Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Felipe Jain, M.D.
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder