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Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-Compulsive Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), November 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00389493
  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

MedlinePlus related topics: Obsessive-Compulsive Disorder
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Maximizing Treatment Outcome in OCD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Obsessive compulsive symptoms [ Time Frame: Measured at Weeks 4 and 8 in Phase I and Weeks 12, 16, 20, 24, 28, and 32 in Phase II ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Adjustment Scale-SR [ Time Frame: Measured at Week 8 in Phase I and Week 32 in Phase II ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at Weeks 4 and 8 in Phase I and Weeks 12, 16, 20, 24, 28, and 32 in Phase II ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: October 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will receive treatment with risperidone
Drug: Risperidone
Dosage of 0.5 mg to 4.0 mg per day as tolerated
2: Active Comparator
Participants will receive exposure and response prevention therapy
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.
3: Placebo Comparator
Participants will receive treatment with the placebo
Drug: Placebo
Placebo capsules will be identical in appearance to those of risperidone.

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.

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

Contacts
Contact: James Bender, Psy.D. 212-543-5462 staubre@nyspi.cpmc.columbia.edu
Contact: Kristin Prasifka, BA 215-746-3332 prasifka@mail.med.upenn.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: James Bender, Psy.D.     212-543-5462        
Contact: Jose Hernandez     212-543-5367        
Principal Investigator: Blair Simpson, MD, PhD            
Sub-Investigator: Michael Liebowitz, MD            
United States, Pennsylvania
University of Pennsylvania Center for the Treatment and Study of Anxiety Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jamie York, BA     215-746-3332        
Principal Investigator: Edna Foa, PhD            
Sub-Investigator: Shawn Cahill, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Blair Simpson, MD, PhD New York State Psychiatric Institute
Principal Investigator: Edna Foa, PhD University of Pennsylvania
  More Information

Click here for the Columbia University Obsessive-Compulsive Disorder Research Clinic website  This link exits the ClinicalTrials.gov site
Click here for the University of Pennsylvania Center for the Treatment and Study of Anxiety website  This link exits the ClinicalTrials.gov site
Click here to view the ClinicalTrials.gov record of this trial's parent study  This link exits the ClinicalTrials.gov site

Responsible Party: New York State Psychiatric Institute ( Blair Simpson, MD, PhD / Study Principal Investigator )
Study ID Numbers: R01 MH45436-06, DSIR 83-ATAS, R01 MH45436, R01 MH45404
Study First Received: October 16, 2006
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00389493  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
OCD
Augmentation
Antipsychotics
Cognitive-Behavioral Therapy

Study placed in the following topic categories:
Dopamine
Anxiety Disorders
Mental Disorders
Risperidone
Serotonin
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 30, 2009