NCT00095524

Brief Summary

The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2004

Geographic Reach
3 countries

32 active sites

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

March 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 11, 2013

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

November 5, 2004

Last Update Submit

November 7, 2013

Conditions

Body Weight ChangeSchizophreniaSchizoaffective DisorderPsychotic Disorder

Keywords

Patient weight changechanges in metabolic status

Outcome Measures

Primary Outcomes (1)

  • Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine

Secondary Outcomes (1)

  • Assessment of metabolic laboratory measures

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Local Institution

Little Rock, Arkansas, United States

Location

Local Institution

Anaheim, California, United States

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Local Institution

Cerritos, California, United States

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Local Institution

Garden Grove, California, United States

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Local Institution

National City, California, United States

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Local Institution

San Diego, California, United States

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Local Institution

New Britain, Connecticut, United States

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Local Institution

North Miami, Florida, United States

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Local Institution

Augusta, Georgia, United States

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Local Institution

Macon, Georgia, United States

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Local Institution

Hoffman Estates, Illinois, United States

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Local Institution

Louisville, Kentucky, United States

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Local Institution

Glen Burnie, Maryland, United States

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Local Institution

Haverhill, Massachusetts, United States

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Local Institution

Worcester, Massachusetts, United States

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Local Institution

Minneapolis, Minnesota, United States

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Local Institution

Brooklyn, New York, United States

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Local Institution

Nashville, Tennessee, United States

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Local Institution

Austin, Texas, United States

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Local Institution

Dallas, Texas, United States

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Local Institution

DeSoto, Texas, United States

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San Antonio, Texas, United States

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Wauwatosa, Wisconsin, United States

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Local Institution

Goibnia, Goiás, Brazil

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Local Institution

Belo Horizonte, Minas Gerais, Brazil

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Local Institution

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, Brazil

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Local Institution

Botucatu, São Paulo, Brazil

Location

Local Institution

Sao Paulo - Sp, São Paulo, Brazil

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Local Institution

São Paulo, São Paulo, Brazil

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Local Institution

Exeter, Devon, United Kingdom

Location

Local Institution

Birmingham, West Midlands, United Kingdom

Location

Related Publications (1)

  • Newcomer JW, Campos JA, Marcus RN, Breder C, Berman RM, Kerselaers W, L'italien GJ, Nys M, Carson WH, McQuade RD. A multicenter, randomized, double-blind study of the effects of aripiprazole in overweight subjects with schizophrenia or schizoaffective disorder switched from olanzapine. J Clin Psychiatry. 2008 Jul;69(7):1046-56. doi: 10.4088/jcp.v69n0702.

    PMID: 18605811DERIVED

MeSH Terms

Conditions

Body Weight ChangesSchizophreniaPsychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 5, 2004

First Posted

November 8, 2004

Study Start

March 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 11, 2013

Record last verified: 2008-05

Locations

US(23)BR(7)GB(2)