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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Maximizing Treatment Outcome in OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389493
• Other study ID #: #5188/#6258R
• Secondary ID: R01MH045436-02DS
• Status: Completed
• Phase: N/A
• First received: October 16, 2006
• Last updated: March 20, 2014
• Start date: October 2006
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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

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.

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	University of Pennsylvania Center for the Treatment and Study of Anxiety	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 fo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Social Adjustment Scale-SR	SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems	Week 0 and Week 8	No
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form	QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life	Week 0 and Week 8	No
Secondary	Hamilton Depression Rating Scale (Ham-D)	Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression	Week 0 and Week 8	No
Secondary	Brown Assessment of Beliefs (BABS)	Scale ranges from 0 to 24 where 0 is "beliefs are false" and 24 is "convinced beliefs = reality"	Week 0 and Week 8	No

External Links

•   Click here for the Columbia University Obsessive-Compulsive Disorder Research Clinic website
•   Click here for The Institute of Living/ Anxiety Disorders Center 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