NCT00095810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
Last Updated

November 8, 2013

Status Verified

December 1, 2010

Enrollment Period

1.2 years

First QC Date

November 9, 2004

Last Update Submit

November 7, 2013

Conditions

Parkinson's DiseasePsychoses

Keywords

Psychosis, Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Tolerability

Secondary Outcomes (1)

  • Safety Assessments

Study Arms (1)

A

EXPERIMENTAL
Drug: aripiprazole

Interventions

aripiprazoleDRUG

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

Also known as: Abilify
A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Albany, New York, United States

Location

Related 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. doi: 10.1002/mds.21091.

    PMID: 17013906BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson DiseasePsychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

July 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

November 8, 2013

Record last verified: 2010-12

Locations

US(1)