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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	Helen Blair Simpson, Research Foundation for Mental Hygiene
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

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:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

Drug Information available for: Risperidone

U.S. FDA Resources

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:	December 2012
Estimated 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 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. 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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Blair Simpson, MD, PhD	New York State Psychiatric Institute
Principal Investigator:	Edna Foa, PhD	University of Pennsylvania

More Information

Additional 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

Click here for the study specific website This link exits the ClinicalTrials.gov site

Click here for The Institute of Living/ Anxiety Disorders Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Helen Blair Simpson, Professor of CLinical Psychiatry, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier:	NCT00389493 History of Changes
Other Study ID Numbers:	R01 MH045436-02, DSIR 83-ATAS, R01 MH45436, R01 MH45404
Study First Received:	October 16, 2006
Last Updated:	January 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

OCD
Augmentation
Antipsychotics
Cognitive-Behavioral Therapy

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental 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 February 12, 2012