Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004826
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinsons Disease
Sponsor:
Memorial Hospital of Rhode Island
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine the efficacy and tolerability of clozapine in ameliorating psychosis in patients with idiopathic Parkinsons 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MHRI-FDR001416 | None | None | None |