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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clozapine
Sponsored by
Memorial Hospital of Rhode Island
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presumed idiopathic Parkinson's disease Presence of three of the cardinal features: Rest tremor Rigidity Bradykinesias/akinesia Postural and balance abnormalities Absence of alternative explanations for the syndrome Absence of atypical features Psychosis of at least 4 weeks duration requiring treatment --Prior/Concurrent Therapy-- Chemotherapy: No concurrent chemotherapy Other: No use of any dopamine blocking drug within the past 3 months No use of depot neuroleptic within the past 12 months No change of antidepressant or anxiolytic dose within the past 1 month No prior clozapine for psychosis Anti-PD medications stable for at least 7 days before study entry --Patient Characteristics-- Hematopoietic: No history of leukopenia No active blood dyscrasia other than mild anemia Renal: No active problems with urinary retention Cardiovascular: No symptomatic orthostatic hypotension No uncontrolled angina No myocardial infarction within the past 3 months Other: Fertile patients must use effective contraception No uncontrolled seizures (i.e., 1 or more seizures per month over the past 6 months) No dementia precluding accurate assessment on psychiatric assessment battery No AIDS No other illness that would make use of clozapine potentially hazardous No narrow angle glaucoma No systemic factor contributing to the psychosis (e.g., urinary infection, liver disease, renal failure, anemia, infection, etc.)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    Memorial Hospital of Rhode Island
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004826
    Brief Title
    Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 1998
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 1997 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Memorial Hospital of Rhode Island

    4. Oversight

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson disease, neurologic and psychiatric disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    clozapine

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presumed idiopathic Parkinson's disease Presence of three of the cardinal features: Rest tremor Rigidity Bradykinesias/akinesia Postural and balance abnormalities Absence of alternative explanations for the syndrome Absence of atypical features Psychosis of at least 4 weeks duration requiring treatment --Prior/Concurrent Therapy-- Chemotherapy: No concurrent chemotherapy Other: No use of any dopamine blocking drug within the past 3 months No use of depot neuroleptic within the past 12 months No change of antidepressant or anxiolytic dose within the past 1 month No prior clozapine for psychosis Anti-PD medications stable for at least 7 days before study entry --Patient Characteristics-- Hematopoietic: No history of leukopenia No active blood dyscrasia other than mild anemia Renal: No active problems with urinary retention Cardiovascular: No symptomatic orthostatic hypotension No uncontrolled angina No myocardial infarction within the past 3 months Other: Fertile patients must use effective contraception No uncontrolled seizures (i.e., 1 or more seizures per month over the past 6 months) No dementia precluding accurate assessment on psychiatric assessment battery No AIDS No other illness that would make use of clozapine potentially hazardous No narrow angle glaucoma No systemic factor contributing to the psychosis (e.g., urinary infection, liver disease, renal failure, anemia, infection, etc.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joseph H. Friedman
    Organizational Affiliation
    Memorial Hospital of Rhode Island
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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