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Parkinson's DiseasePhase 4NCT00095810

Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

A Phase 4 study testing aripiprazole in people with Parkinson's Disease and Psychoses, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Parkinson's Disease, Psychoses
What is being tested?
aripiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jul 2003to Sep 2004
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Local Institution

    Albany, New York

Other trials in United States

About this study

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

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.

Being tested
aripiprazole
Keywords
Psychosis, Parkinson's Disease
Medical subject headings
Parkinson Disease, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aripiprazoleDrug

    Also called Abilify

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

Study groups in NCT00095810
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability

Secondary outcomes (1)
  1. Safety Assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study startJul 2003
  3. Primary completionSep 2004
  4. Study completionSep 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095810
Sponsor's protocol ID
CN138-060
Status last verified
Dec 2010
First submitted
9 Nov 2004
Last updated
8 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 17013906

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