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

New York State Psychiatric Institute

Status: Completed

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Placebo; Drug: Risperidone; Behavioral: Exposure/ritual prevention therapy (EX/RP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00389493

DSIR 83-ATAS

#5188/#6258R

R01MH045436 (U.S. NIH Grant/Contract)

R01MH045436-02 (U.S. NIH Grant/Contract)

R01MH045404 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

100 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Participants will receive treatment with risperidone

Treatment:

Drug: Risperidone

2

Active Comparator group

Description:

Participants will receive exposure and ritual prevention therapy (EX/RP)

Treatment:

Behavioral: Exposure/ritual prevention therapy (EX/RP)

3

Placebo Comparator group

Description:

Participants will receive treatment with the placebo

Treatment:

Drug: Placebo