- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00484471
ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness (ABLE)
March 29, 2022 updated by: Korea Otsuka International Asia Arab
A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder
To compare combination treatment of aripiprazole plus valproate versus valproate alone in the prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6 weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode, with or without psychotic features.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Further study details as provided by Korea OIAA
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tuen Mun, Hong Kong
- Castle Peak Hospital
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Mandaluyong, Philippines
- National Center for Mental Health
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Manila, Philippines
- Philippine General Hospital
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Manila, Philippines
- University of Sto. Tomas Hospital
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Quezon, Philippines
- Veterans Medical Memorial Center
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Changhua, Taiwan
- Changhua Chrisitian Hospital
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Nantou, Taiwan
- Tsao-Tun Psychiatric Center
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Tainan, Taiwan
- Jia-Nan Mental Hospital
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Tainan, Taiwan
- National Cheng-Kung University Hospital
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Taipei, Taiwan
- Tri-Service General Hospital
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Taoyuan, Taiwan
- Taoyuan Mental Hospital
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Bangkok, Thailand
- Siriraj Hospital
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Bangkok, Thailand
- Somdej Chaophraya Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects able to give informed consent, and/or consent obtained from a legally acceptable representative (as required by IRB/IEC) prior to the initiation of any protocol required procedures;
- Subjects with Bipolar I Disorder, manic or mixed episode, with or without psychotic features, as defined by DSM-IV-TR and confirmed by the M.I.N.I.;
- Subjects who are able to understand the nature of the study and follow protocol requirements including the prescribed dosage regimens, capsule/tablet ingestion, discontinuation of prohibited concomitant medications, and who can be reliably rated on assessment scales;
- Subjects willing to discontinue all medication starting from the signing of the informed consent and during the study phases (allowed exceptions noted in Section 6.4.2);
- Men or women aged ≥ 18 and ≤ 65 years;
- Subjects with YMRS total score ≥ 20 (to be assessed prior entry into open-label acute treatment phase);
- YMRS total score ≤ 12 for 2 consecutive visits (to be assessed at Week 5 and/or Week6 prior entry into double-blind treatment phase).
Exclusion Criteria:
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to four weeks after completion of the study. Acceptable methods include oral, injectable or implanted contraceptives, intrauterine devices or barrier methods such as condoms, diaphragm, and spermicides;
- Women who are pregnant or breast-feeding;
- Subjects presenting clinically with a current DSM-IV-TR diagnosis of delirium, dementia, amnestic or other cognitive disorders, or a psychotic disorder (e.g., schizophrenia or schizoaffective disorder). Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder;
- Subjects with a current Axis I (DSM-IV-TR) diagnosis of Bipolar II Disorder, rapid cyclers (experiencing four or more manic or depressive episodes per year), Bipolar Disorder NOS, or any other primary psychiatric disorder other than Bipolar I Disorder;
- Subjects with documented evidence of first manic episode;
- Subjects considered treatment refractory for manic symptoms; (Note: if a subject has failed ≥ 2 antimanic treatments, e.g., antipsychotic, lithium, valproate or carbamazepine at therapeutic dose and duration, exclusive of the current episode, obtain permission from the Otsuka medical monitor to include the subject)
- Subjects previously nonresponsive to aripiprazole for manic symptoms;
- Subjects with a significant risk of committing suicide based on history, mental status exam, or investigator's judgment;
- Subjects who have met DSM-IV-TR criteria for substance abuse within the past three months, or substance dependence* within the past 6 months, including benzodiazepines; (* exceptional for subjects with substance dependence on nicotine or caffeine);
- Subjects with thyroid pathology (e.g., hypothyroidism or hyperthyroidism) unless condition has been stabilized with medications for at least the past three months; (Note: Subjects with an abnormal thyroid function test may be retested prior to the start of study medication. Subjects with an abnormal thyroid function test at screening will not be eligible for the study, unless permission is obtained from Otsuka);
- Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison's Disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;
- Subjects with a significant history of seizure disorder (e.g., epilepsy);
The following laboratory tests results, vital signs, and ECG findings are exclusionary:
- Platelets ≤ 75000/mm3
- Hemoglobin ≤ 9g/dL
- Neutrophils, absolute ≤ 1000/ mm3
- SGOT (AST) > 3x Upper Limit of Normal
- SGPT (ALT) > 3x Upper Limit of Normal
- Creatinine ≥ 2 mg/dL
- QTc > 475 msec
- Subjects with a recent antipsychotic use who have a CPK ≥ 550 IU (Otsuka should be contacted to discuss any elevated CPK levels);
- Subjects who are known to be allergic, intolerant, or unresponsive to valproate or to aripiprazole;
- Subjects with a history of neuroleptic malignant syndrome from antipsychotic agents;
- Subjects likely to require prohibited concomitant therapy during the study as indicated in Section 6.4 of the protocol;
- Recent treatment of their most recent manic or mixed acute episode with a long acting antipsychotic in which the last dose was less than one full cycle plus one week prior to entering Phase 2 (haloperidol decanoate treatment within the past five weeks, fluphenazine decanoate treatment within the past three weeks or Risperdal ConstaTM treatment within the past three weeks);
- Subjects likely to require the initiation of intensive individual psychotherapy during the course of the study (Note: Group and supportive therapy is allowed, if part of the subject's ongoing treatment. Individual psychotherapy is allowed if the subject has consistently received psychotherapy for at least 3 months prior to the study and will continue during the study);
- ECT treatment within the current episode or within two months prior to the study;
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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15-30 mg/day aripiprazole, 22 weeks
Other Names:
sufficient dose as determined by investigator to maintain the therapeutic level.
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Placebo Comparator: 2
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sufficient dose as determined by investigator to maintain the therapeutic level.
placebo to aripiprazole, 22 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to relapse in double-blind treatment phase
Time Frame: throughout the study
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throughout the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change from baseline to all time point in YMRS total score;
Time Frame: throughout the study
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throughout the study
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Mean change from baseline to all time points in MADRS total score
Time Frame: throughout the study
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throughout the study
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Response rate (≥ 50% improvement in YMRS total score) at all time points
Time Frame: throughout the study
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throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Nan-Ying Chiu, MD, Changhua Christian Hospital, TAIWAN
- Principal Investigator: Hun-Yu Chang, MD, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
- Principal Investigator: Yen-Kung Yang, MD, National Cheng-Kung University Hospital
- Principal Investigator: Wen-Chen Ouyang, MD, Jia-Nan Mental Hospital
- Principal Investigator: Wei-Wen Lin, MD, Tri-Service General Hospital
- Principal Investigator: Tso-Ren Wang, MD, Tsao-Tun Psychistric Center
- Principal Investigator: Efren Reyes, MD, National Center for Mental Health (NCMH)
- Principal Investigator: Rosanna de Guzman, MD, Philippine General Hospital (PGH)
- Principal Investigator: Gabino Ranoa, MD, University of Sto. Tomas Hospital (USTH)
- Principal Investigator: Amadeo Alinea, Veterans Medical Memorial Center (VMMC)
- Principal Investigator: .Vasu Chantarasak, MD, Somdej Chaophraya Hospital
- Principal Investigator: Suttiporn Janenawasin, MD, Siriraj Hospital
- Principal Investigator: F K Tsang, MD, Castle Peak Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
June 8, 2007
First Submitted That Met QC Criteria
June 8, 2007
First Posted (Estimate)
June 11, 2007
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Aripiprazole
- Valproic Acid
Other Study ID Numbers
- 031-OTB-0701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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