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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

October 16, 2006
March 20, 2014
October 2006
June 2012   (final data collection date for primary outcome measure)
Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity
Obsessive compulsive symptoms (measured at Weeks 4 and 8; measured at Weeks 12, 16, 20, 24, 28, and 32 for participants in Phase II)
Complete list of historical versions of study NCT00389493 on ClinicalTrials.gov Archive Site
  • Social Adjustment Scale-SR [ Time Frame: Week 0 and Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"
  • Social Adjustment Scale-SR
  • Quality of Life (measured at Weeks 4 and 8; measured at Weeks 12, 16, 20, 24, 28, and 32 for participants in Phase II)
Not Provided
Not Provided
 
Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Maximizing Treatment Outcome in OCD

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • Drug: Risperidone
    Dosage of 0.5 mg to 4.0 mg per day as tolerated
    Other Name: Risperdal
  • 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
  • Drug: Placebo
    Placebo capsules will be identical in appearance to those of risperidone.
    Other Name: PBO
  • Active Comparator: 1
    Participants will receive treatment with risperidone
    Intervention: Drug: Risperidone
  • Active Comparator: 2
    Participants will receive exposure and ritual prevention therapy (EX/RP)
    Intervention: Behavioral: Exposure/ritual prevention therapy (EX/RP)
  • Placebo Comparator: 3
    Participants will receive treatment with the placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00389493
#5188/#6258R, R01MH045436-02, DSIR 83-ATAS, R01 MH45436, R01 MH45404
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Blair Simpson, MD, PhD New York State Psychiatric Institute
Principal Investigator: Edna Foa, PhD University of Pennsylvania
New York State Psychiatric Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP