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Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00389493
First received: October 16, 2006
Last updated: March 20, 2014
Last verified: October 2013
Results First Received: October 29, 2013  
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
Condition: Obsessive-Compulsive Disorder
Interventions: Drug: Risperidone
Behavioral: Exposure/ritual prevention therapy (EX/RP)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A randomized clinical trial (conducted January 2007-August 2012) at 2 academic outpatient research clinics that specialize in OCD and anxiety disorders. Patients (aged 18-70 years) were eligible if they had OCD of at least moderate severity despite a therapeutic SRI dose for at least 12 weeks prior to entry.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment With Risperidone

Participants will receive treatment with risperidone

Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated

Treatment With Exposure/Response Prevention

Participants will receive exposure and response prevention therapy

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.

Treatment With Pill Placebo

Participants will receive treatment with the placebo

Placebo : Placebo capsules will be identical in appearance to those of risperidone.


Participant Flow:   Overall Study
    Treatment With Risperidone     Treatment With Exposure/Response Prevention     Treatment With Pill Placebo  
STARTED     40     40     20  
COMPLETED     37     32     17  
NOT COMPLETED     3     8     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment With Risperidone

Participants will receive treatment with risperidone

Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated

Treatment With Exposure/Response Prevention

Participants will receive exposure and response prevention therapy

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.

Treatment With Pill Placebo

Participants will receive treatment with the placebo

Placebo : Placebo capsules will be identical in appearance to those of risperidone.

Total Total of all reporting groups

Baseline Measures
    Treatment With Risperidone     Treatment With Exposure/Response Prevention     Treatment With Pill Placebo     Total  
Number of Participants  
[units: participants]
  40     40     20     100  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     40     20     100  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 10.8     34.3  ± 12.7     33.4  ± 10.4     33.9  ± 11.4  
Gender  
[units: participants]
       
Female     21     21     6     48  
Male     19     19     14     52  
Region of Enrollment  
[units: participants]
       
United States     40     40     20     100  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)   [ Time Frame: Week 0 and Week 8 ]

2.  Secondary:   Social Adjustment Scale-SR   [ Time Frame: Week 0 and Week 8 ]

3.  Secondary:   Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form   [ Time Frame: Week 0 and Week 8 ]

4.  Secondary:   Hamilton Depression Rating Scale (Ham-D)   [ Time Frame: Week 0 and Week 8 ]

5.  Secondary:   Brown Assessment of Beliefs (BABS)   [ Time Frame: Week 0 and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Helen Blair Simpson
Organization: New York State Psychiatric Institute
phone: 646-774-7000
e-mail: kimeldo@nyspi.columbia.edu


Publications of Results:
Publications automatically indexed to this study:

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
Results First Received: October 29, 2013
Last Updated: March 20, 2014
Health Authority: United States: Federal Government