Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for 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