Trials / Completed
CompletedNCT01686087
Attaining and Maintaining Wellness in Obsessive-compulsive Disorder
Attaining and Maintaining Wellness in OCD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 137 (actual)
- Sponsor
- New York State Psychiatric Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2018-06-01
- Completion
- 2018-07-01
- First posted
- 2012-09-17
- Last updated
- 2019-03-13
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01686087. Inclusion in this directory is not an endorsement.