Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2R01MH045436-18 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuation of SRI | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly Booster Sessions of EX/RP | Behavioral | 45 minute EXRP booster sessions each month |
|
| 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 |
| 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) |
Not provided
Preparatory Phase
Inclusion Criteria:
Exclusion Criteria:
Study Phase
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helen B Simpson, MD PhD | NY State Psychiatric Institute at Columbia University | Principal Investigator |
| Edna Foa, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States | ||
| University of Pennsylvania Center for the Treatment and Study of Anxiety |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39879875 | Derived | Wheaton MG, Kalanthroff E, Mandel M, Marsh R, Simpson HB. Neurocognitive performance in obsessive-compulsive disorder before and after treatment with cognitive behavioral therapy. J Behav Ther Exp Psychiatry. 2025 Jun;87:102019. doi: 10.1016/j.jbtep.2025.102019. Epub 2025 Jan 20. | |
| 35080598 | Derived | Foa EB, Simpson HB, Gallagher T, Wheaton MG, Gershkovich M, Schmidt AB, Huppert JD, Imms P, Campeas RB, Cahill S, DiChiara C, Tsao SD, Puliafico A, Chazin D, Asnaani A, Moore K, Tyler J, Steinman SA, Sanches-LaCay A, Capaldi S, Snorrason I, Turk-Karan E, Vermes D, Kalanthroff E, Pinto A, Hamlett GE, Middleton R, Hahn CG, Xu B, Van Meter PE, Katechis M, Rosenfield D. Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Mar 1;79(3):193-200. doi: 10.1001/jamapsychiatry.2021.3997. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Visits with MD and independent evaluators | Procedure | All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms. |
|
| 6 months |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |