Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

NCT ID: NCT00095810

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease Psychoses

Keywords

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Psychosis, Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

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

Interventions

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aripiprazole

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

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Albany, New York, United States

Site Status

Countries

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United States

References

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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. doi: 10.1002/mds.21091.

Reference Type BACKGROUND
PMID: 17013906 (View on PubMed)

Related Links

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Other Identifiers

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CN138-060

Identifier Type: -

Identifier Source: org_study_id