Body Weight ChangePhase 3NCT00095524
Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing Aripiprazole in people with Body Weight Change and Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 32 sites in 3 countries.
Trial summary
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Weight Change, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Aripiprazole
- How many people
- 300 participants
- Where
- 32 sitesin 3 countries
- Study dates
- Mar 2004to Aug 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Who cannot join
None listed.
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States23 sites
Local Institution
Anaheim, California
Local Institution
Augusta, Georgia
Local Institution
Austin, Texas
Local Institution
Brooklyn, New York
Local Institution
Cerritos, California
Local Institution
Dallas, Texas
Local Institution
DeSoto, Texas
Local Institution
Garden Grove, California
Local Institution
Glen Burnie, Maryland
Local Institution
Haverhill, Massachusetts
Local Institution
Hoffman Estates, Illinois
Local Institution
Little Rock, Arkansas
Local Institution
Louisville, Kentucky
Local Institution
Macon, Georgia
Local Institution
Minneapolis, Minnesota
Local Institution
Nashville, Tennessee
Local Institution
National City, California
Local Institution
New Britain, Connecticut
Local Institution
North Miami, Florida
Local Institution
San Antonio, Texas
Local Institution
San Diego, California
Local Institution
Wauwatosa, Wisconsin
Local Institution
Worcester, Massachusetts
Brazil7 sites
Local Institution
Belo Horizonte, Minas Gerais
Local Institution
Botucatu, São Paulo
Local Institution
Goibnia, Goiás
Local Institution
Porto Alegre, Rio Grande do Sul
Local Institution
Rio de Janeiro, Rio de Janeiro
Local Institution
São Paulo, São Paulo
Local Institution
Sao Paulo - Sp, São Paulo
United Kingdom2 sites
Local Institution
Birmingham, West Midlands
Local Institution
Exeter, Devon
About this study
Official title: A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.
- Being tested
- Aripiprazole
- Keywords
- Patient weight change, changes in metabolic status
- Medical subject headings
- Body Weight Changes, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2004 (estimated)
- Study startMar 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangeStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00095524
- Sponsor's protocol ID
- CN138-122
- Status last verified
- May 2008
- First submitted
- 5 Nov 2004
- Last updated
- 11 Nov 2013
- Results posted
- No
Publications
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.
PubMed 18605811
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind Study on the Effects of Aripiprazole in Overweight Patients Treated With Olanzapine for Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00095524
- Acronym / sponsor ID
- CN138-122
- Keywords
- Patient weight change, changes in metabolic status
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Mar 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the affects of aripiprazole and olanzapine on weight change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients diagnosed with schizophrenia or schizoaffective disorder who are currently taking olanzapine.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
1 secondary outcome
Assessment of metabolic laboratory measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Derived from this study: PubMed 18605811Newcomer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole in people with Body Weight Change and Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Brazil, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00095524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.