Bipolar DisorderPhase 3NCT00097266
Study of Aripiprazole in Patients With Acute Bipolar Mania
A Phase 3 study testing Aripiprazole and Haloperidol in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 45 sites in 7 countries.
Trial summary
The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania. 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 and Haloperidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 615 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Dec 2004to Jan 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
- Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
Who cannot join
None listed.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
United States15 sites
Local Institution
Albuquerque, New Mexico
Local Institution
Anaheim, California
Local Institution
Cerritos, California
Local Institution
Cleveland, Ohio
Local Institution
DeSoto, Texas
Local Institution
Garden Grove, California
Local Institution
Maitland, Florida
Local Institution
National City, California
Local Institution
Oklahoma City, Oklahoma
Local Institution
Pico Rivera, California
Local Institution
Riverside, California
Local Institution
San Diego, California
Local Institution
Shreveport, Louisiana
Local Institution
Tampa, Florida
Local Institution
Washington D.C., District of Columbia
Russia9 sites
Local Institution
Arkhangelsk
Local Institution
Kazan'
Local Institution
Leningrad Region
Local Institution
Lipetsk, Lipetsk Oblast
Local Institution
Moscow
Local Institution
Nizhny Novgorod
Local Institution
Saint Petersburg
Local Institution
Samara
Local Institution
Volgograd
Mexico7 sites
Local Institution
Col. Obispado, Nuevo León
Local Institution
Fracc. Industrias, San Luis Potosí
Local Institution
Mérida, Yucatán
Local Institution
Mexico City, Mexico City
Local Institution
Monterrey, Nuevo León
Local Institution
Nuevo León
Local Institution
Zapopan, Jalisco
Bulgaria5 sites
Local Institution
Burgas
Local Institution
Novi Iskar
Local Institution
Pleven
Local Institution
Sofia
Local Institution
Varna
Croatia4 sites
Local Institution
Osijek
Local Institution
Rijeka
Local Institution
Split
Local Institution
Zagreb
South Africa4 sites
Local Institution
Berea, Kwa Zuluu Natal
Local Institution
Durban, KwaZulu-Natal
Local Institution
Florida, Gauteng
Local Institution
Pretoria, Gauteng
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 research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
- Conditions
- Bipolar Disorder
- Being tested
- Placebo, Aripiprazole, Haloperidol
- 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.
PlaceboDrug
Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).
AripiprazoleDrug
Also called Abilify
Tablets, oral, 15-30 mg, once daily, 12 weeks.
HaloperidolDrug
Capsule, oral, 5-15 mg, once daily, 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Aripiprazole |
| C | Active comparator | Not described Receives: Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in a mania rating scale at endpoint
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 posted22 Nov 2004 (estimated)
- Study startDec 2004
- Primary completionJan 2007
- Study completionJan 2007
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 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
- Treatment
- 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
- NCT00097266
- Sponsor's protocol ID
- CN138-162
- Status last verified
- Jul 2010
- First submitted
- 19 Nov 2004
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.
PubMed 19118324
Study at a glance
From the registry record, last updated by the sponsor on 8 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
- NCT00097266
- Acronym / sponsor ID
- CN138-162
- 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
- Dec 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 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 research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Experimental | Drug: Aripiprazole |
| C | Active comparator | Drug: Haloperidol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.
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 |
|---|---|---|
| PlaceboTablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks). | Drug | A |
| AripiprazoleAlso: AbilifyTablets, oral, 15-30 mg, once daily, 12 weeks. | Drug | B |
| HaloperidolCapsule, oral, 5-15 mg, once daily, 12 weeks. | Drug | C |
Primary outcome
Change in a mania rating scale at endpoint
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 8 Nov 2013.
- Background: PubMed 19118324Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.
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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
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and Haloperidol in people with Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 45 sites in 7 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 8 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 45 sites in United States, Russia, Mexico, Bulgaria, Croatia and 2 more countries. 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?
Change in a mania rating scale at endpoint. 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 NCT00097266, 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 8 Nov 2013.