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

NCT00004826 | Completed

• 2 other identifiers: 199/13295MHRI-FDR001416
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; neurologic and psychiatric disorders; rare disease

Interventions

clozapine DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Hospital of Rhode Island: lead

MeSH Terms

Conditions

Parkinson Disease; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph H. Friedman

  Memorial Hospital of Rhode Island

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: October 1, 1993
• Study Completion: November 1, 1997
• Last Updated: March 25, 2015

Record last verified: 1998-05