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
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Drug: Risperidone
Behavioral: Exposure/ritual prevention therapy (EX/RP)
Drug: Placebo

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
Official Title: Maximizing Treatment Outcome in OCD

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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"


Enrollment: 100
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive treatment with risperidone
Drug: Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
Other Name: Risperdal
Active Comparator: 2
Participants will receive exposure and ritual prevention therapy (EX/RP)
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
Placebo Comparator: 3
Participants will receive treatment with the placebo
Drug: Placebo
Placebo capsules will be identical in appearance to those of risperidone.
Other Name: PBO

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389493

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania Center for the Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Blair Simpson, MD, PhD New York State Psychiatric Institute
Principal Investigator: Edna Foa, PhD University of Pennsylvania
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by New York State Psychiatric Institute:
OCD
Augmentation
Antipsychotics
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on October 16, 2014