A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy
1 other identifier
interventional
1,270
9 countries
83
Brief Summary
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2005
Longer than P75 for phase_4
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 1, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
April 27, 2011
CompletedApril 18, 2023
March 1, 2023
3.8 years
December 1, 2005
January 28, 2011
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3
Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS \> 16 and/or a MADRS \> 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS \> 16 and/or a MADRS \> 16.
Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Secondary Outcomes (123)
Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3
Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2
Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)
Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3
Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
- +118 more secondary outcomes
Study Arms (2)
A1
PLACEBO COMPARATOR/Active Comparator
A2
EXPERIMENTALInterventions
Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily
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
Eligibility Criteria
You may qualify if:
- Men and women \> or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Tuscaloosa Va Medical Center
Tuscaloosa, Alabama, 35404, United States
Pravin Kansagra, M.D.
Anaheim, California, 92801, United States
Psychopharmacology Research Network Of Torrance
Cerritos, California, 90703, United States
Atp Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Us Clinical Research Centers, Llc
Costa Mesa, California, 92627, United States
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Synergy Clinical Research Center
National City, California, 91950, United States
University Of California, Irvine Medical Center
Orange, California, 92868, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
University Of South Florida
Tampa, Florida, 33613, United States
Carman Research
Smyrna, Georgia, 30080, United States
University Of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
Psych Care Consultants Research
St Louis, Missouri, 63128, United States
Cns Research Institute, P.C.
Clementon, New Jersey, 08021, United States
Neuropsychiatric Research Associates
New York, New York, 10128, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Psychiatry And Clinical Research
Raleigh, North Carolina, 27609, United States
Rakesh Ranjan, Md & Associates, Inc.
Beachwood, Ohio, 44122, United States
University Of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Portland Va Medical Center
Portland, Oregon, 97201, United States
Senior Adults Specialty Research, Inc.
Austin, Texas, 78757, United States
Futuresearch Trials
Dallas, Texas, 75231, United States
Insite Clinical Research
DeSoto, Texas, 75115, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090, United States
University Of Utah School Of Medicine
Salt Lake City, Utah, 84132, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Local Institution
Salvador, Estado de Bahia, 40325, Brazil
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Aparecida de Goinia, Goiás, 74922, Brazil
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Pelotas, Rio Grande do Sul, 96030 003, Brazil
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Rio de Janeiro, 21020, Brazil
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São Paulo, 02340, Brazil
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São Paulo, 05403, Brazil
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Burgas, 8000, Bulgaria
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Rousse, 7002, Bulgaria
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Rijeka, 51-000, Croatia
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Split, 21000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10 090, Croatia
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Brno, 610 00, Czechia
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Brno, 625 00, Czechia
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Havířov, 736 01, Czechia
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Litoměřice, 412 01, Czechia
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Prague, 120 00, Czechia
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Prague, 160 00, Czechia
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Přerov, 75002, Czechia
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Nantes, Cedex 01, 44035, France
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Dole, 39100, France
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Hénin-Beaumont, 62251, France
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Jonzac, 175003, France
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La Seyne-sur-Mer, 83500, France
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Marseille, 13009, France
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Nantes, 44000, France
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Nîmes, 30900, France
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Rennes, 35000, France
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Hyderabad, Andhra Pradesh, 500 034, India
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Ahmedabad, Gujarat, 380 006, India
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Ahmedabad, Gujarat, 6577647, India
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Kalyan (West), Maharashtra, 421 301, India
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Nāgūr, Maharashtra, 440010, India
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Pune, Maharashtra, 400 001, India
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Mangalore, Manipal, 576 104, India
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Mumbai, Sion (W), 400 022, India
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Delhi, 110 092, India
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Hyderabad, 500 038, India
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Mumbai, 400 008, India
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Mumbai, 400 058, India
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New Delhi, 110 002, India
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New Delhi, 110 065, India
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Izhevsk, 426053, Russia
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Moscow, 107258, Russia
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Nizhny Novgorod, 603107, Russia
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Saint Petersburg, 190000, Russia
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Saint Petersburg, 191119, Russia
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Saratov, 410028, Russia
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Tomsk, 634014, Russia
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Pretoria, Gauteng, 0001, South Africa
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Berea, KwaZulu-Natal, 4001, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Cape Town, Western Cape, 7708, South Africa
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Paarl, Western Cape, 7646, South Africa
Related Publications (1)
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.
PMID: 21443567DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2005
First Posted
December 5, 2005
Study Start
September 1, 2005
Primary Completion
June 1, 2009
Study Completion
October 1, 2009
Last Updated
April 18, 2023
Results First Posted
April 27, 2011
Record last verified: 2023-03