Bipolar I DisorderPhase 3NCT00094432
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
A Phase 3 study testing Aripiprazole in people with Bipolar I Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 40 sites in United States.
Trial summary
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 40 sitesUnited States
- Study dates
- Jun 2004to Nov 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
- Men and women, ages 18-65
- Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
Who cannot join
None listed.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Local Institution
Albuquerque, New Mexico
Local Institution
Baltimore, Maryland
Local Institution
Bellevue, Washington
Local Institution
Brooklyn, New York
Local Institution
Charleston, West Virginia
Local Institution
Charlottesville, Virginia
Local Institution
Clementon, New Jersey
Local Institution
Columbia, South Carolina
Local Institution
Coral Springs, Florida
Local Institution
Dayton, Ohio
Local Institution
DeSoto, Texas
Local Institution
Edwardsville, Illinois
Local Institution
Elmsford, New York
Local Institution
Houston, Texas
Local Institution
Jacksonville, Florida
Local Institution
La Mesa, California
Local Institution
La Palma, California
Local Institution
Lafayette, Indiana
Local Institution
Long Beach, California
Local Institution
Marietta, Georgia
Local Institution
Media, Pennsylvania
Local Institution
Mesa, Arizona
Local Institution
Midlothian, Virginia
Local Institution
New Orleans, Louisiana
Local Institution
New York, New York
Local Institution
Newton, Kansas
Local Institution
Oak Brook, Illinois
Local Institution
Philadelphia, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania
Local Institution
Raleigh, North Carolina
Local Institution
Redlands, California
Local Institution
Salt Lake City, Utah
Local Institution
San Diego, California
Local Institution
Sherman Oaks, California
Local Institution
Shreveport, Louisiana
Local Institution
Springfield, Illinois
Local Institution
St Louis, Missouri
Local Institution
St. Petersburg, Florida
Local Institution
Washington D.C., District of Columbia
Local Institution
Wichita Falls, Texas
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
- Conditions
- Bipolar I Disorder
- Being tested
- Aripiprazole, Placebo
- Keywords
- depressed
- Medical subject headings
- Consciousness 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, 10mg (2 5mg tablets), Once daily, 8 weeks.
PlaceboDrug
Tablets, Oral, 0 mg, Once daily, 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Aripiprazole |
| A2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to endpoint on the MADRS total score.
Secondary outcomes (3)
Clinical Global Impression - Bipolar Version
Severity of illness score depression
Mean change from baseline to endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2004 (estimated)
- Study startJun 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 650 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
- NCT00094432
- Sponsor's protocol ID
- CN138-146
- Status last verified
- Jun 2008
- First submitted
- 18 Oct 2004
- Last updated
- 11 Nov 2013
- Results posted
- No
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 in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.
- ClinicalTrials.gov ID
- NCT00094432
- Acronym / sponsor ID
- CN138-146
- Conditions
- Bipolar I Disorder
- Keywords
- depressed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jun 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Oct 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 study is to evaluate several doses of aripiprazole in patients with bipolar depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Aripiprazole |
| A2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women, ages 18-65
- Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyTablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks. | Drug | A1 |
| PlaceboTablets, Oral, 0 mg, Once daily, 8 weeks. | Drug | A2 |
Primary outcome
Mean change from baseline to endpoint on the MADRS total score.
3 secondary outcomes
Clinical Global Impression - Bipolar Version
Severity of illness score depression
Mean change from baseline to 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.
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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
40 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 I Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 40 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 2 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 40 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. Some participants in this study may receive a placebo. 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?
Mean change from baseline to endpoint on the MADRS total score.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.