Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obsessive-Compulsive Disorder |
Drug: Risperidone Behavioral: Exposure/ritual prevention therapy (EX/RP) Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Maximizing Treatment Outcome in OCD |
- Obsessive compulsive symptoms [ Time Frame: Measured at Weeks 4 and 8 in Phase I and Weeks 12, 16, 20, 24, 28, and 32 in Phase II ] [ Designated as safety issue: No ]
- Social Adjustment Scale-SR [ Time Frame: Measured at Week 8 in Phase I and Week 32 in Phase II ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Measured at Weeks 4 and 8 in Phase I and Weeks 12, 16, 20, 24, 28, and 32 in Phase II ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 115 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive treatment with risperidone
|
Drug: Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
Other Name: Risperdal
|
|
Active Comparator: 2
Participants will receive exposure and response prevention therapy
|
Behavioral: Exposure/ritual prevention therapy (EX/RP)
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.
Other Name: EX/RP
|
|
Placebo Comparator: 3
Participants will receive treatment with the placebo
|
Drug: Placebo
Placebo capsules will be identical in appearance to those of risperidone.
Other Name: PBO
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| University of Pennsylvania Center for the Treatment and Study of Anxiety | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Blair Simpson, MD, PhD | New York State Psychiatric Institute |
| Principal Investigator: | Edna Foa, PhD | University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00389493 History of Changes |
| Other Study ID Numbers: | #5188/#6258R, R01MH045436-02, DSIR 83-ATAS, R01 MH45436, R01 MH45404 |
| Study First Received: | October 16, 2006 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York State Psychiatric Institute:
|
OCD Augmentation Antipsychotics Cognitive-Behavioral Therapy |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 16, 2013