A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
NCT ID: NCT00261443
Last Updated: 2023-04-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1270 participants
INTERVENTIONAL
2005-09-30
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Aripiprazole in Patients With Bipolar I Disorder
NCT00257972
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
NCT00665366
Study of Aripiprazole in Patients With Acute Bipolar Mania
NCT00097266
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
NCT00606229
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
NCT00094432
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A1
/Active Comparator
Lithium or Valproate with placebo (PBO)
Tablets, Oral, once daily
lithium 250-2100 mg/day
valproate 250-2500mg/day
Placebo once daily
A2
Lithium or Valproate with Aripiprazole
Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
lithium 250-2100 mg/day
valproate 250-2500mg/day
aripiprazole 15-30 mg/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lithium or Valproate with placebo (PBO)
Tablets, Oral, once daily
lithium 250-2100 mg/day
valproate 250-2500mg/day
Placebo once daily
Lithium or Valproate with Aripiprazole
Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
lithium 250-2100 mg/day
valproate 250-2500mg/day
aripiprazole 15-30 mg/day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tuscaloosa Va Medical Center
Tuscaloosa, Alabama, United States
Pravin Kansagra, M.D.
Anaheim, California, United States
Psychopharmacology Research Network Of Torrance
Cerritos, California, United States
Atp Clinical Research, Inc.
Costa Mesa, California, United States
Us Clinical Research Centers, Llc
Costa Mesa, California, United States
Va Long Beach Healthcare System
Long Beach, California, United States
Synergy Clinical Research Center
National City, California, United States
University Of California, Irvine Medical Center
Orange, California, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
University Of South Florida
Tampa, Florida, United States
Carman Research
Smyrna, Georgia, United States
University Of Massachusetts Medical School
Worcester, Massachusetts, United States
Psych Care Consultants Research
St Louis, Missouri, United States
Cns Research Institute, P.C.
Clementon, New Jersey, United States
Neuropsychiatric Research Associates
New York, New York, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Psychiatry And Clinical Research
Raleigh, North Carolina, United States
Rakesh Ranjan, Md & Associates, Inc.
Beachwood, Ohio, United States
University Of Cincinnati Medical Center
Cincinnati, Ohio, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Portland Va Medical Center
Portland, Oregon, United States
Senior Adults Specialty Research, Inc.
Austin, Texas, United States
Futuresearch Trials
Dallas, Texas, United States
Insite Clinical Research
DeSoto, Texas, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, United States
University Of Utah School Of Medicine
Salt Lake City, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Local Institution
Salvador, Estado de Bahia, Brazil
Local Institution
Aparecida de Goinia, Goiás, Brazil
Local Institution
Pelotas, Rio Grande do Sul, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Burgas, , Bulgaria
Local Institution
Rousse, , Bulgaria
Local Institution
Rijeka, , Croatia
Local Institution
Split, , Croatia
Local Institution
Zadar, , Croatia
Local Institution
Zagreb, , Croatia
Local Institution
Brno, , Czechia
Local Institution
Brno, , Czechia
Local Institution
Havířov, , Czechia
Local Institution
Litoměřice, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Přerov, , Czechia
Local Institution
Nantes, Cedex 01, France
Local Institution
Dole, , France
Local Institution
Hénin-Beaumont, , France
Local Institution
Jonzac, , France
Local Institution
La Seyne-sur-Mer, , France
Local Institution
Marseille, , France
Local Institution
Nantes, , France
Local Institution
Nîmes, , France
Local Institution
Rennes, , France
Local Institution
Hyderabad, Andhra Pradesh, India
Local Institution
Ahmedabad, Gujarat, India
Local Institution
Ahmedabad, Gujarat, India
Local Institution
Kalyan (West), Maharashtra, India
Local Institution
Nāgūr, Maharashtra, India
Local Institution
Pune, Maharashtra, India
Local Institution
Mangalore, Manipal, India
Local Institution
Mumbai, Sion (W), India
Local Institution
Delhi, , India
Local Institution
Hyderabad, , India
Local Institution
Mumbai, , India
Local Institution
Mumbai, , India
Local Institution
New Delhi, , India
Local Institution
New Delhi, , India
Local Institution
Izhevsk, , Russia
Local Institution
Moscow, , Russia
Local Institution
Nizhny Novgorod, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saratov, , Russia
Local Institution
Tomsk, , Russia
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Berea, KwaZulu-Natal, South Africa
Local Institution
Durban, KwaZulu-Natal, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Paarl, Western Cape, South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CN138-189
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.