<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/NCT01686087</url>
  </required_header>
  <id_info>
    <org_study_id>6628</org_study_id>
    <secondary_id>2R01MH045436-18</secondary_id>
    <nct_id>NCT01686087</nct_id>
  </id_info>
  <brief_title>Attaining and Maintaining Wellness in Obsessive-compulsive Disorder</brief_title>
  <official_title>Attaining and Maintaining Wellness in OCD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to understand whether patients with obsessive-compulsive disorder&#xD;
      (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral&#xD;
      therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if&#xD;
      they first do well with EX/RP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study begins with a Preparatory Phase, wherein all eligible participants receive up to&#xD;
      25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory&#xD;
      Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase.&#xD;
      Those who do not achieve wellness will not continue in the study and are referred for&#xD;
      treatment elsewhere. Those who enter the Study Phase are then assigned by chance to one of&#xD;
      two groups. One group will continue on the SRI medication and the other group will&#xD;
      discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill).&#xD;
      Neither patients nor study staff will know which group a participant is in. Both groups will&#xD;
      continue to receive monthly sessions of EX/RP. The study will examine who has the best&#xD;
      response to treatment in this study, including taking blood samples for genetic testing to&#xD;
      see whether there are genes that can predict who will or will not benefit from EX/RP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Obsessive Compulsive Symptom Severity (Y-BOCS)</measure>
    <time_frame>6 months</time_frame>
    <description>In study phase, to determine whether those who have achieved wellness with Cognitive Behavioral Therapy who are on medication can maintain wellness when medication is stopped</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive severity (HAMD17)</measure>
    <time_frame>6 months</time_frame>
    <description>Hamilton Depression Scale (HAMD, 17 item)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QLESQ-S)</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of Life Satisfaction Questionnaire (QLESQ, short form)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Obsessive Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Continuation of SRI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to stay on SRI. They will receive 45 minute EX/RP booster sessions once per month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Replace SRI w/placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to gradual replacement with pill placebo. They will receive 45 minute EX/RP booster sessions once per month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monthly Booster Sessions of EX/RP</intervention_name>
    <description>45 minute EXRP booster sessions each month</description>
    <arm_group_label>Continuation of SRI</arm_group_label>
    <arm_group_label>Replace SRI w/placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Visits with MD and independent evaluators</intervention_name>
    <description>All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.</description>
    <arm_group_label>Continuation of SRI</arm_group_label>
    <arm_group_label>Replace SRI w/placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Preparatory Phase&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of OCD&#xD;
&#xD;
          -  Currently on a stable and adequate dose of a serotonin reuptake inhibitor (i.e.,&#xD;
             clomipramine, fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram,&#xD;
             escitalopram) but still have clinically significant OCD symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid Psychiatric conditions that significantly elevate the risks of study&#xD;
             participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or&#xD;
             other cognitive disorder, suicidality)&#xD;
&#xD;
          -  Unstable medical conditions that need attention and would make participation in the&#xD;
             study unsafe (e.g., very high blood pressure)&#xD;
&#xD;
          -  Patients who have already had prior adjunctive EX/RP (more than 8 sessions within 2&#xD;
             months) while receiving an adequate SRI trial&#xD;
&#xD;
          -  Patients taking other medications besides an SRI (e.g. antipsychotics, mood&#xD;
             stabilizers, other antidepressants besides SRIs)&#xD;
&#xD;
          -  Patients who are pregnant, sexually active and not using contraception, or nursing&#xD;
&#xD;
        Study Phase&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the&#xD;
             Study Phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All exclusions listed above for Preparatory Phase are exclusions for Study Phase as&#xD;
             well&#xD;
&#xD;
          -  Patients who are depressed at the end of the Preparatory phase are excluded from Study&#xD;
             Phase&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen B Simpson, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NY State Psychiatric Institute at Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edna Foa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Center for the Treatment and Study of Anxiety</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Helen Blair Simpson</investigator_full_name>
    <investigator_title>Professor of Clinical Psychiatry, College of Physicians and Surgeons, Columbia University Director of the Anxiety Disorders Clinic and OCD Research Program, New York State Psychiatric Institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive 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/NCT01686087
org study id: 6628
secondary id: 2R01MH045436-18
nct id: NCT01686087
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this study is to understand whether patients with obsessive-compulsive disorder
      (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral
      therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if
      they first do well with EX/RP.
This study begins with a Preparatory Phase, wherein all eligible participants receive up to
      25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory
      Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase.
      Those who do not achieve wellness will not continue in the study and are referred for
      treatment elsewhere. Those who enter the Study Phase are then assigned by chance to one of
      two groups. One group will continue on the SRI medication and the other group will
      discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill).
      Neither patients nor study staff will know which group a participant is in. Both groups will
      continue to receive monthly sessions of EX/RP. The study will examine who has the best
      response to treatment in this study, including taking blood samples for genetic testing to
      see whether there are genes that can predict who will or will not benefit from EX/RP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Obsessive Compulsive Symptom Severity (Y-BOCS)
time frame: 6 months
description: In study phase, to determine whether those who have achieved wellness with Cognitive Behavioral Therapy who are on medication can maintain wellness when medication is stopped
measure: Depressive severity (HAMD17)
time frame: 6 months
description: Hamilton Depression Scale (HAMD, 17 item)
measure: Quality of Life (QLESQ-S)
time frame: 6 months
description: Quality of Life Satisfaction Questionnaire (QLESQ, short form)
arm group label: Continuation of SRI
arm group type: Active Comparator
description: Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to stay on SRI. They will receive 45 minute EX/RP booster sessions once per month.
arm group label: Replace SRI w/placebo
arm group type: Placebo Comparator
description: Patients who achieve minimal to mild OCD symptoms and are not currently depressed at end of preparatory phase will be randomized to gradual replacement with pill placebo. They will receive 45 minute EX/RP booster sessions once per month.
intervention type: Behavioral
intervention name: Monthly Booster Sessions of EX/RP
description: 45 minute EXRP booster sessions each month
arm group label: Continuation of SRI
arm group label: Replace SRI w/placebo
intervention type: Procedure
intervention name: Visits with MD and independent evaluators
description: All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.
arm group label: Continuation of SRI
arm group label: Replace SRI w/placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Helen B Simpson, MD PhD
role: Principal Investigator
affiliation: NY State Psychiatric Institute at Columbia University
last name: Edna Foa, PhD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Helen Blair Simpson
investigator title: Professor of Clinical Psychiatry, College of Physicians and Surgeons, Columbia University Director of the Anxiety Disorders Clinic and OCD Research Program, New York State Psychiatric Institute
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder