Attaining and Maintaining Wellness in Obsessive-compulsive Disorder

New York State Psychiatric Institute

Status: Completed

Conditions: Obsessive Compulsive Disorder

Treatments: Procedure: Visits with MD and independent evaluators; Behavioral: Monthly Booster Sessions of EX/RP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01686087

6628 (Other Identifier)

2R01MH045436-18 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups, including a placebo group

Continuation of SRI

Active Comparator group

Description:

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.

Treatment:

Procedure: Visits with MD and independent evaluators

Behavioral: Monthly Booster Sessions of EX/RP

Replace SRI w/placebo

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Visits with MD and independent evaluators

Behavioral: Monthly Booster Sessions of EX/RP