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Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00095810
Enrollment
50
Registered
2004-11-09
Start date
2003-07-31
Completion date
2004-09-30
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Psychoses

Keywords

Psychosis, Parkinson's Disease

Brief summary

The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.

Interventions

DRUGaripiprazole

Tablets, Oral, 1-10mg, Once daily, 6 weeks.

Sponsors

Otsuka America Pharmaceutical
CollaboratorINDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary diagnosis of idiopathic Parkinson's disease. * Psychosis related to Parkinson's disease.

Exclusion criteria

* Psychosis present prior to diagnosis of Parkinson's disease.

Design outcomes

Primary

MeasureTime frame
Tolerability—

Secondary

MeasureTime frame
Safety Assessments—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026