Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095810
• Other study ID #: CN138-060
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2004
• Last updated: November 7, 2013
• Start date: July 2003
• Est. completion date: September 2004

Study information

• Verified date: December 2010
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson's Disease
• Psychoses
• Psychotic Disorders

Intervention

Drug:
• aripiprazole
Tablets, Oral, 1-10mg, Once daily, 6 weeks.

Locations

Country	Name	City	State
United States	Local Institution	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Friedman JH, Berman RM, Goetz CG, Factor SA, Ondo WG, Wojcieszek J, Carson WH, Marcus RN. Open-label flexible-dose pilot study to evaluate the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease. Mov Disord. 2006 Dec;21(12):2078-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability
Secondary	Safety Assessments

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
•   PhRMA website-CSR Synopsis