Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clozapine Treatment of Schizophrenic Patients|
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at baseline and every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]Scale assesses psychotic symptoms on a 20-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe.
- Neuropsychological Testing [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Active
Participants assigned to risperidone
Risperdal 4 mg per day for 16 weeks
Other Name: Risperidone
Placebo Comparator: Placebo
Participants assigned to placebo
Placebo capsule daily for 16 weeks
Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy.
Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Baltimore, Maryland, United States, 21228|
|Principal Investigator:||Robert W Buchanan, MD||University of Maryland|