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ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness (ABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00484471
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka International Asia Arab

Tracking Information
First Submitted Date  ICMJE June 8, 2007
First Posted Date  ICMJE June 11, 2007
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2007)
Time to relapse in double-blind treatment phase [ Time Frame: throughout the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2007)
  • Mean change from baseline to all time point in YMRS total score; [ Time Frame: throughout the study ]
  • Mean change from baseline to all time points in MADRS total score [ Time Frame: throughout the study ]
  • Response rate (≥ 50% improvement in YMRS total score) at all time points [ Time Frame: throughout the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness
Official Title  ICMJE A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder
Brief Summary 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.
Detailed Description Further study details as provided by Korea OIAA
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: aripiprazole
    15-30 mg/day aripiprazole, 22 weeks
    Other Name: Abilify
  • Drug: valproate
    sufficient dose as determined by investigator to maintain the therapeutic level.
  • Drug: placebo
    placebo to aripiprazole, 22 weeks
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: aripiprazole
    • Drug: valproate
  • Placebo Comparator: 2
    Interventions:
    • Drug: valproate
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2012)
127
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2007)
280
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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;
  2. 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.;
  3. 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;
  4. 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);
  5. Men or women aged ≥ 18 and ≤ 65 years;
  6. Subjects with YMRS total score ≥ 20 (to be assessed prior entry into open-label acute treatment phase);
  7. 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:

  1. 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;
  2. Women who are pregnant or breast-feeding;
  3. 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;
  4. 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;
  5. Subjects with documented evidence of first manic episode;
  6. 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)
  7. Subjects previously nonresponsive to aripiprazole for manic symptoms;
  8. Subjects with a significant risk of committing suicide based on history, mental status exam, or investigator's judgment;
  9. 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);
  10. 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);
  11. 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;
  12. Subjects with a significant history of seizure disorder (e.g., epilepsy);
  13. 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
  14. Subjects with a recent antipsychotic use who have a CPK ≥ 550 IU (Otsuka should be contacted to discuss any elevated CPK levels);
  15. Subjects who are known to be allergic, intolerant, or unresponsive to valproate or to aripiprazole;
  16. Subjects with a history of neuroleptic malignant syndrome from antipsychotic agents;
  17. Subjects likely to require prohibited concomitant therapy during the study as indicated in Section 6.4 of the protocol;
  18. 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);
  19. 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);
  20. ECT treatment within the current episode or within two months prior to the study;
  21. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Philippines,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00484471
Other Study ID Numbers  ICMJE 031-OTB-0701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Korea Otsuka International Asia Arab
Study Sponsor  ICMJE Korea Otsuka International Asia Arab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Korea Otsuka International Asia Arab
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP