Clinical trial NCT00389493: Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder
Official title: Maximizing Treatment Outcome in OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Augmentation
Antipsychotics
Cognitive-Behavioral Therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Week 0 and Week 8
Secondary outcomes:
measure: Social Adjustment Scale-SR
timeFrame: Week 0 and Week 8
measure: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
timeFrame: Week 0 and Week 8
measure: Hamilton Depression Rating Scale (Ham-D)
timeFrame: Week 0 and Week 8
measure: Brown Assessment of Beliefs (BABS)
timeFrame: Week 0 and Week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: New York State Psychiatric Institute
name: Blair Simpson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Edna Foa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simpson HB, Foa EB, Liebowitz MR, Huppert JD, Cahill S, Maher MJ, McLean CP, Bender J Jr, Marcus SM, Williams MT, Weaver J, Vermes D, Van Meter PE, Rodriguez CI, Powers M, Pinto A, Imms P, Hahn CG, Campeas R. Cognitive-behavioral therapy vs risperidone for augmenting serotonin reuptake inhibitors in obsessive-compulsive disorder: a randomized clinical trial. JAMA Psychiatry. 2013 Nov;70(11):1190-9. doi: 10.1001/jamapsychiatry.2013.1932.
citation: McLean CP, Zandberg LJ, Van Meter PE, Carpenter JK, Simpson HB, Foa EB. Exposure and response prevention helps adults with obsessive-compulsive disorder who do not respond to pharmacological augmentation strategies. J Clin Psychiatry. 2015 Dec;76(12):1653-7. doi: 10.4088/JCP.14m09513.
citation: Foa EB, Simpson HB, Rosenfield D, Liebowitz MR, Cahill SP, Huppert JD, Bender J Jr, McLean CP, Maher MJ, Campeas R, Hahn CG, Imms P, Pinto A, Powers MB, Rodriguez CI, Van Meter PE, Vermes D, Williams MT. Six-month outcomes from a randomized trial augmenting serotonin reuptake inhibitors with exposure and response prevention or risperidone in adults with obsessive-compulsive disorder. J Clin Psychiatry. 2015 Apr;76(4):440-6. doi: 10.4088/JCP.14m09044.
citation: Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.