NCT00004826

Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Memorial Hospital of Rhode Island · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine the efficacy and tolerability of clozapine in ameliorating psychosis in patients with idiopathic Parkinson's disease (PD). II. Determine the adverse effects of clozapine on motor function in this patient population. III. Determine the safety of clozapine in psychotic PD patients taking multiple anti-PD medications. IV. Describe the phenomenology of drug induced psychosis in PD.

Detailed description

PROTOCOL OUTLINE: This is a randomized, placebo controlled, double blind study, followed by an open label treatment of all patients. Patients are stratified according to the institutional investigator and age. In the first phase of the study, patients receive either clozapine or placebo. The drug is taken orally at night, approximately 30 minutes before retiring. Therapy continues for 4 weeks unless psychosis becomes unmanageable without hospitalization, parkinsonism worsens, or other adverse effects occur. It is possible that the dose may be escalated. In the second phase of the study, all patients are treated with open label clozapine. Therapy continues for 3 months unless psychiatric status or parkinsonism progress. Dose escalation is also possible during this phase. Patients are followed weekly during the first phase of the study, and monthly during the second phase. Completion date provided represents the completion date of the grant per OOPD records

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	clozapine

Timeline

• Start date: 1993-10-01
• Completion: 1997-11-01
• First posted: 2000-02-25
• Last updated: 2015-03-25