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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: FDA Office of Orphan Products Development
Memorial Hospital of Rhode Island
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00004826
  Purpose

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.


Condition Intervention
Parkinson Disease
Drug: clozapine

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease    Psychotic Disorders   

Drug Information available for:   Clozapine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:   60
Study Start Date:   October 1993

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004826

Sponsors and Collaborators
FDA Office of Orphan Products Development
Memorial Hospital of Rhode Island

Investigators
Study Chair:     Joseph H. Friedman     Memorial Hospital of Rhode Island    
  More Information


Study ID Numbers:   199/13295, MHRI-FDR001416
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004826
Health Authority:   United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Parkinson disease  
neurologic and psychiatric disorders  
rare disease  

Study placed in the following topic categories:
Ganglion Cysts
Basal Ganglia Diseases
Rare Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Serotonin
Parkinson Disease
Mental Disorders
Movement Disorders
Clozapine
Psychotic Disorders
Parkinsonian Disorders

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 03, 2008




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