Bipolar DisorderPhase 3NCT00095511
Aripiprazole in Patients With Acute Mania
A Phase 3 study testing aripiprazole in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 38 sites in United States.
Trial summary
The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- aripiprazole
- How many people
- 615 participants
- Where
- 38 sitesUnited States
- Study dates
- Jun 2004to May 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Acute Bipolar I Mania
Who cannot join
- Patients with a DSM-IV diagnosis other than Bipolar I Mania
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Local Institution
Arlington, Virginia
Local Institution
Augusta, Georgia
Local Institution
Austin, Texas
Local Institution
Bellaire, Texas
Local Institution
Bradenton, Florida
Local Institution
Cedarhurst, New York
Local Institution
Cerritos, California
Local Institution
Chicago, Illinois
Local Institution
Cincinnati, Ohio
Local Institution
Clementon, New Jersey
Local Institution
Cleveland, Ohio
Local Institution
Denver, Colorado
Local Institution
Elmsford, New York
Local Institution
Garden Grove, California
Local Institution
Hoffman Estates, Illinois
Local Institution
Holliswood, New York
Local Institution
Honolulu, Hawaii
Local Institution
Houston, Texas
Local Institution
Indianapolis, Indiana
Local Institution
Kissimmee, Florida
Local Institution
La Palma, California
Local Institution
Louisville, Kentucky
Local Institution
Lyndhurst, Ohio
Local Institution
Maitland, Florida
Local Institution
Middletown, Connecticut
Local Institution
Morganton, North Carolina
Local Institution
New Haven, Connecticut
Local Institution
New Orleans, Louisiana
Local Institution
Norristown, Pennsylvania
Local Institution
Oklahoma City, Oklahoma
Local Institution
Philadelphia, Pennsylvania
Local Institution
Raleigh, North Carolina
Local Institution
Riverside, California
Local Institution
Saint Charles, Missouri
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San Diego, California
Local Institution
Scottsdale, Arizona
Local Institition
Shreveport, Louisiana
Local Institution
Tuscaloosa, Alabama
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
The purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
- Conditions
- Bipolar Disorder
- Being tested
- aripiprazole
- Keywords
- Bipolar Mania
- Medical subject headings
- Bipolar Disorder
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.
Change from baseline to endpoint in a mania rating scale
Secondary outcomes (1)
Response rate and Clinical Global Impression scale at endpoint
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 startJun 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 615 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
- NCT00095511
- Sponsor's protocol ID
- CN138-135
- Status last verified
- May 2008
- First submitted
- 5 Nov 2004
- Last updated
- 11 Nov 2013
- Results posted
- No
Publications
Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.
PubMed 18835043McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.
PubMed 22454801
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, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00095511
- Acronym / sponsor ID
- CN138-135
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jun 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (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 purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of Acute Bipolar I Mania
Key exclusion criteria (1 listed)
- Patients with a DSM-IV diagnosis other than Bipolar I Mania
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
Change from baseline to endpoint in a mania rating scale
1 secondary outcome
Response rate and Clinical Global Impression scale at endpoint
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.
- Background: PubMed 18835043Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, McQuade RD, Carson WH; CN138-135 Study Group. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1-3):36-49. doi: 10.1016/j.jad.2008.05.014. Epub 2008 Oct 2.
- Derived from this study: PubMed 22454801McIntyre RS, McElroy SL, Eudicone JM, Forbes RA, Carlson BX, Baker RA. A 52-week, double-blind evaluation of the metabolic effects of aripiprazole and lithium in bipolar I disorder. Prim Care Companion CNS Disord. 2011;13(6):PCC.11m01182. doi: 10.4088/PCC.11m01182.
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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
38 sites in 1 country: 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 Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 38 sites in United States.
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 1 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 38 sites in United States. 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?
Change from baseline to endpoint in a mania rating scale. 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 NCT00095511, which also lists 2 linked publications.
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.