Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Registration Number
- NCT00389493
- Lead Sponsor
- New York State Psychiatric Institute
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Primary diagnosis of OCD
- Currently on a stable and adequate dose of an SRI
- Sufficient severity of symptoms to warrant additional augmentation treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 3 Placebo Participants will receive treatment with the placebo 1 Risperidone Participants will receive treatment with risperidone 2 Exposure/ritual prevention therapy (EX/RP) Participants will receive exposure and ritual prevention therapy (EX/RP)
- Primary Outcome Measures
Name Time Method Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Week 0 and Week 8 Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
- Secondary Outcome Measures
Name Time Method Social Adjustment Scale-SR Week 0 and Week 8 SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form Week 0 and Week 8 QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life
Hamilton Depression Rating Scale (Ham-D) Week 0 and Week 8 Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression
Brown Assessment of Beliefs (BABS) Week 0 and Week 8 Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
Trial Locations
- Locations (2)
University of Pennsylvania Center for the Treatment and Study of Anxiety
🇺🇸Philadelphia, Pennsylvania, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States