Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

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.
    

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
    

Intervention name(s): Risperidone; Exposure/ritual prevention therapy (EX/RP); Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Dosage of 0.5 mg to 4.0 mg per day as tolerated; 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.; Placebo capsules will be identical in appearance to those of risperidone.
Other intervention name(s): Risperdal; EX/RP; PBO
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Augmentation; Antipsychotics; Cognitive-Behavioral Therapy