Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Maximizing Treatment Outcome in OCD
5 other identifiers
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
April 25, 2014
CompletedApril 25, 2014
October 1, 2013
5.7 years
October 16, 2006
October 29, 2013
March 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
Week 0 and Week 8
Secondary Outcomes (4)
Social Adjustment Scale-SR
Week 0 and Week 8
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
Week 0 and Week 8
Hamilton Depression Rating Scale (Ham-D)
Week 0 and Week 8
Brown Assessment of Beliefs (BABS)
Week 0 and Week 8
Study Arms (3)
1
ACTIVE COMPARATORParticipants will receive treatment with risperidone
2
ACTIVE COMPARATORParticipants will receive exposure and ritual prevention therapy (EX/RP)
3
PLACEBO COMPARATORParticipants will receive treatment with the placebo
Interventions
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 capsules will be identical in appearance to those of risperidone.
Eligibility Criteria
You may qualify if:
- Primary diagnosis of OCD
- Currently on a stable and adequate dose of an SRI
- Sufficient severity of symptoms to warrant additional augmentation treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
New York State Psychiatric Institute
New York, New York, 10032, United States
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104, United States
Related Publications (4)
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.
PMID: 24026523RESULTMcLean 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.
PMID: 26613263DERIVEDFoa 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.
PMID: 25375780DERIVEDFarris 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.
PMID: 23945445DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Helen Blair Simpson
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Blair Simpson, MD, PhD
New York State Psychiatric Institute
- PRINCIPAL INVESTIGATOR
Edna Foa, PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 18, 2006
Study Start
October 1, 2006
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
April 25, 2014
Results First Posted
April 25, 2014
Record last verified: 2013-10