Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Monthly Booster Sessions of EX/RP

Intervention Type BEHAVIORAL

45 minute EXRP booster sessions each month

Visits with MD and independent evaluators

Intervention Type PROCEDURE

All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.

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.

Group Type PLACEBO_COMPARATOR

Monthly Booster Sessions of EX/RP

Intervention Type BEHAVIORAL

45 minute EXRP booster sessions each month

Visits with MD and independent evaluators

Intervention Type PROCEDURE

All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.

Interventions

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Monthly Booster Sessions of EX/RP

45 minute EXRP booster sessions each month

Intervention Type BEHAVIORAL

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Helen Blair Simpson

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

Responsibility Role PRINCIPAL_INVESTIGATOR