Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01686087
First received: September 12, 2012
Last updated: September 17, 2014
Last verified: August 2014

September 12, 2012
September 17, 2014
October 2012
October 2016   (final data collection date for primary outcome measure)
Obsessive Compulsive Symptom Severity (Y-BOCS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Obsessive Compulsive Symptom Severity (Y-BOCS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
In study phase, to determine whether those who have achieved wellness with CBT who are on medication can maintain wellness when medication is stopped
Complete list of historical versions of study NCT01686087 on ClinicalTrials.gov Archive Site
  • Depressive severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Attaining and Maintaining Wellness in Obsessive-compulsive Disorder
Attaining and Maintaining Wellness in OCD

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • Behavioral: Monthly Booster Sessions of EX/RP
    45 minute EXRP booster sessions each month
  • Procedure: Visits with MD and independent evaluators
    All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.
  • Active Comparator: Continuation of SRI
    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.
    Interventions:
    • Behavioral: Monthly Booster Sessions of EX/RP
    • Procedure: Visits with MD and independent evaluators
  • Placebo Comparator: Replace SRI w/placebo
    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.
    Interventions:
    • Behavioral: Monthly Booster Sessions of EX/RP
    • Procedure: Visits with MD and independent evaluators
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
October 2016
October 2016   (final data collection date for primary outcome measure)

Preparatory Phase

Inclusion Criteria:

  • Primary diagnosis of OCD
  • Currently on a stable and adequate dose of a serotonin reuptake inhibitor (i.e., clomipramine, fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram) but still have clinically significant OCD symptoms

Exclusion Criteria:

  • Comorbid Psychiatric conditions that significantly elevate the risks of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g., very high blood pressure)
  • Patients who have already had prior adjunctive EX/RP (more than 8 sessions within 2 months) while receiving an adequate SRI trial
  • Patients taking other medications besides an SRI (e.g. antipsychotics, mood stabilizers, other antidepressants besides SRIs)
  • Patients who are pregnant, sexually active and not using contraception, or nursing

Study Phase

Inclusion Criteria:

  • Those who achieve mild to minimum OCD symptoms from Preparatory Phase will enter the Study Phase

Exclusion Criteria:

  • All exclusions listed above for Preparatory Phase are exclusions for Study Phase as well
  • Patients who are depressed at the end of the Preparatory phase are excluded from Study Phase
Both
18 Years to 75 Years
No
Contact: Helen B Simpson, MD, Ph.D. 646-774-7000
Contact: Marissa Schwartz, B.A. 646-774-8062
United States
 
NCT01686087
6628, 2R01MH045436-18
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Helen B Simpson, MD PhD NY State Psychiatric Institute at Columbia University
Principal Investigator: Edna Foa, PhD University of Pennsylvania
New York State Psychiatric Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP