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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00389493 |
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 |
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Obsessive-Compulsive Disorder |
Drug: Risperidone Behavioral: Exposure/ritual prevention therapy (EX/RP) Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Maximizing Treatment Outcome in OCD |
Estimated Enrollment: | 115 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will receive treatment with risperidone
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Drug: Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
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2: Active Comparator
Participants will receive exposure and response prevention therapy
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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.
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3: Placebo Comparator
Participants will receive treatment with the placebo
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Drug: Placebo
Placebo capsules will be identical in appearance to those of risperidone.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: James Bender, Psy.D. | 212-543-5462 | staubre@nyspi.cpmc.columbia.edu |
Contact: Kristin Prasifka, BA | 215-746-3332 | prasifka@mail.med.upenn.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: James Bender, Psy.D. 212-543-5462 | |
Contact: Jose Hernandez 212-543-5367 | |
Principal Investigator: Blair Simpson, MD, PhD | |
Sub-Investigator: Michael Liebowitz, MD | |
United States, Pennsylvania | |
University of Pennsylvania Center for the Treatment and Study of Anxiety | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jamie York, BA 215-746-3332 | |
Principal Investigator: Edna Foa, PhD | |
Sub-Investigator: Shawn Cahill, PhD |
Principal Investigator: | Blair Simpson, MD, PhD | New York State Psychiatric Institute |
Principal Investigator: | Edna Foa, PhD | University of Pennsylvania |
Responsible Party: | New York State Psychiatric Institute ( Blair Simpson, MD, PhD / Study Principal Investigator ) |
Study ID Numbers: | R01 MH45436-06, DSIR 83-ATAS, R01 MH45436, R01 MH45404 |
Study First Received: | October 16, 2006 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00389493 |
Health Authority: | United States: Federal Government |
OCD Augmentation Antipsychotics Cognitive-Behavioral Therapy |
Dopamine Anxiety Disorders Mental Disorders |
Risperidone Serotonin Obsessive-Compulsive Disorder |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |