Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
NCT ID: NCT00389493
Last Updated: 2014-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2006-10-31
2012-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants will receive treatment with risperidone
Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
2
Participants will receive exposure and ritual prevention therapy (EX/RP)
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.
3
Participants will receive treatment with the placebo
Placebo
Placebo capsules will be identical in appearance to those of risperidone.
Interventions
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Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
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.
Placebo
Placebo capsules will be identical in appearance to those of risperidone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently on a stable and adequate dose of an SRI
* Sufficient severity of symptoms to warrant additional augmentation treatment
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Blair Simpson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Edna Foa, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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New York State Psychiatric Institute
New York, New York, United States
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States
Countries
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References
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Simpson HB, Foa EB, Liebowitz MR, Huppert JD, Cahill S, Maher MJ, McLean CP, Bender J Jr, Marcus SM, Williams MT, Weaver J, Vermes D, Van Meter PE, Rodriguez CI, Powers M, Pinto A, Imms P, Hahn CG, Campeas R. Cognitive-behavioral therapy vs risperidone for augmenting serotonin reuptake inhibitors in obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2013 Nov;70(11):1190-9. doi: 10.1001/jamapsychiatry.2013.1932.
McLean CP, Zandberg LJ, Van Meter PE, Carpenter JK, Simpson HB, Foa EB. Exposure and response prevention helps adults with obsessive-compulsive disorder who do not respond to pharmacological augmentation strategies. J Clin Psychiatry. 2015 Dec;76(12):1653-7. doi: 10.4088/JCP.14m09513.
Foa EB, Simpson HB, Rosenfield D, Liebowitz MR, Cahill SP, Huppert JD, Bender J Jr, McLean CP, Maher MJ, Campeas R, Hahn CG, Imms P, Pinto A, Powers MB, Rodriguez CI, Van Meter PE, Vermes D, Williams MT. Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder. J Clin Psychiatry. 2015 Apr;76(4):440-6. doi: 10.4088/JCP.14m09044.
Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.
Related Links
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Click here for the Columbia University Obsessive-Compulsive Disorder Research Clinic website
Click here for the University of Pennsylvania Center for the Treatment and Study of Anxiety website
Click here to view the ClinicalTrials.gov record of this trial's parent study
Other Identifiers
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DSIR 83-ATAS
Identifier Type: -
Identifier Source: secondary_id
#5188/#6258R
Identifier Type: -
Identifier Source: org_study_id
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