Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

Study Overview
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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.

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.

Official Title
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Attaining and Maintaining Wellness in OCD

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Behavioral: Monthly Booster Sessions of EX/RP
* Procedure: Visits with MD and independent evaluators


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuation of SRI<br>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<br>* 45 minute EXRP booster sessions each month<br>Procedure: Visits with MD and independent evaluators<br>* All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.<br>|
| Placebo Comparator: Replace SRI w/placebo<br>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<br>* 45 minute EXRP booster sessions each month<br>Procedure: Visits with MD and independent evaluators<br>* All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive Compulsive Symptom Severity (Y-BOCS) | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive severity (HAMD17) | Hamilton Depression Scale (HAMD, 17 item) | 6 months | 
| Quality of Life (QLESQ-S) | Quality of Life Satisfaction Questionnaire (QLESQ, short form) | 6 months |