Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Behavioral: Monthly Booster Sessions of EX/RP; Procedure: Visits with MD and independent evaluators

• Registration Number: NCT01686087
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-17
• Study Start: 2012-10
• Primary Completion: 2018-06
• Study Completion: 2018-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuation of SRI	Monthly Booster Sessions of EX/RP	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.
Replace SRI w/placebo	Monthly Booster Sessions of EX/RP	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.
Continuation of SRI	Visits with MD and independent evaluators	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.
Replace SRI w/placebo	Visits with MD and independent evaluators	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.

Primary Outcome Measures

Name	Time	Method
Obsessive Compulsive Symptom Severity (Y-BOCS)	6 months	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

Name	Time	Method
Depressive severity (HAMD17)	6 months	Hamilton Depression Scale (HAMD, 17 item)
Quality of Life (QLESQ-S)	6 months	Quality of Life Satisfaction Questionnaire (QLESQ, short form)

Trial Locations

Locations (2)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

University of Pennsylvania Center for the Treatment and Study of Anxiety; 🇺🇸 Philadelphia, Pennsylvania, United States