Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
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| ClinicalTrials.gov Identifier: NCT00389493 |
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Recruitment Status :
Completed
First Posted : October 18, 2006
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obsessive-Compulsive Disorder | Drug: Risperidone Behavioral: Exposure/ritual prevention therapy (EX/RP) Drug: Placebo | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Maximizing Treatment Outcome in OCD |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
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
Other Name: Risperdal |
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Active Comparator: 2
Participants will receive exposure and ritual prevention therapy (EX/RP)
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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.
Other Name: EX/RP |
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Placebo Comparator: 3
Participants will receive treatment with the placebo
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Drug: Placebo
Placebo capsules will be identical in appearance to those of risperidone.
Other Name: PBO |
- Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Week 0 and Week 8 ]Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
- Social Adjustment Scale-SR [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 0 and Week 8 ]Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389493
| 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00389493 |
| Other Study ID Numbers: |
#5188/#6258R R01MH045436-02 ( U.S. NIH Grant/Contract ) DSIR 83-ATAS R01MH045436 ( U.S. NIH Grant/Contract ) R01MH045404 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 18, 2006 Key Record Dates |
| Results First Posted: | April 25, 2014 |
| Last Update Posted: | April 25, 2014 |
| Last Verified: | October 2013 |
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OCD Augmentation Antipsychotics Cognitive-Behavioral Therapy |
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Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents |