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Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

This study is currently recruiting participants.
Verified March 2013 by New York State Psychiatric Institute
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01686087
First received: September 12, 2012
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
 Behavioral: Monthly Booster Sessions of EX/RP
Procedure: Visits with MD and independent evaluators
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attaining and Maintaining Wellness in OCD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Depressive severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686087

Contacts
Contact: Helen B Simpson, MD, Ph.D. 212-543-5367

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact     212-543-5462        
Principal Investigator: Helen B Simpson, MD Ph.D.            
United States, Pennsylvania
University of Pennsylvania Center for the Treatment and Study of Anxiety Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact     215-746-3327        
Principal Investigator: Edna Foa, Ph.D.            
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Helen B Simpson, MD PhD NY State Psychiatric Institute at Columbia University
Principal Investigator: Edna Foa, PhD University of Pennsylvania
  More Information

Additional Information:
For more information about the study, please visit this study-specific website.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01686087     History of Changes
Other Study ID Numbers: 6628, 2R01MH045436-18
Study First Received: September 12, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013