Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
This study will compare the short- and long-term effectiveness of two common therapies in improving serotonin reuptake inhibitor treatment in people with obsessive-compulsive disorder.

Detailed Description
-----------------
Obsessive-compulsive disorder (OCD) is a common psychiatric illness. People with OCD experience unwelcome thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. Impairment due to OCD symptoms ranges from mild to severe, and sometimes can be disabling. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Cognitive-behavioral therapy (CBT), a talking therapy that focuses on altering a person's thoughts and behaviors, and the medication risperidone have both been commonly used for augmenting SRI treatment for OCD. This study will compare the short- and long-term effectiveness of exposure and ritual prevention (EX/RP), a type of CBT, and risperidone in augmenting SRI treatment in people with OCD. Participants in this double-blind study will be randomly assigned to receive EX/RP, risperidone, or placebo in conjunction with their regular SRI medication. All participants will remain on their regular SRI at a stable dose. During the first 2 months of the study, participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response. Participants assigned to risperidone or placebo will meet with a psychiatrist once every 1 to 2 weeks. At the end of 8 weeks, all participants' OCD symptom severity will be assessed. During this time, participants who have responded to treatment will continue receiving the same treatment for an additional 24 weeks. Participants assigned to EX/RP will meet with a therapist no more than 15 times total, and participants receiving risperidone or placebo will meet with a psychiatrist once every 4 weeks. Outcomes will be reassessed at study completion. Ortho McNeil Janssen Scientific Affairs, LLC are providing medication and placebos for this study. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00045903

Official Title
-----------------
Maximizing Treatment Outcome in OCD

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Risperidone
* Behavioral: Exposure/ritual prevention therapy (EX/RP)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of OCD Currently on a stable and adequate dose of an SRI Sufficient severity of symptoms to warrant additional augmentation treatment Exclusion Criteria: Medical or psychiatric conditions that would make participation in the study unsafe Currently receiving psychotherapy elsewhere at the time of study entry Previously (within 12 weeks prior to study entry) attended 8 or more sessions of EX/RP within a 2-month period or received at least 4 weeks of antipsychotic augmentation while on an adequate SRI dose Currently being treated with an SRI for the first time and has not yet responded, but has not tried another SRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants will receive treatment with risperidone | Drug: Risperidone<br>* Dosage of 0.5 mg to 4.0 mg per day as tolerated<br>* Other names: Risperdal;|
| Active Comparator: 2<br>Participants will receive exposure and ritual prevention therapy (EX/RP) | Behavioral: Exposure/ritual prevention therapy (EX/RP)<br>* EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.<br>* Other names: EX/RP;|
| Placebo Comparator: 3<br>Participants will receive treatment with the placebo | Drug: Placebo<br>* Placebo capsules will be identical in appearance to those of risperidone.<br>* Other names: PBO;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity | Week 0 and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Adjustment Scale-SR | SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems | Week 0 and Week 8 | 
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form | QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life | Week 0 and Week 8 | 
| Hamilton Depression Rating Scale (Ham-D) | Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression | Week 0 and Week 8 | 
| Brown Assessment of Beliefs (BABS) | Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality | Week 0 and Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCD, Augmentation, Antipsychotics, Cognitive-Behavioral Therapy