Obsessive Compulsive Disorder
Conditions
Brief 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.
Interventions
BEHAVIORALMonthly Booster Sessions of EX/RP
45 minute EXRP booster sessions each month
PROCEDUREVisits 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.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obsessive Compulsive Symptom Severity (Y-BOCS) | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive severity (HAMD17) | 6 months | Hamilton Depression Scale (HAMD, 17 item) |
| Quality of Life (QLESQ-S) | 6 months | Quality of Life Satisfaction Questionnaire (QLESQ, short form) |
Countries
United States
Outcome results
None listed