ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness

NCT00484471 | Completed Phase 4

• 1 other identifier: 031-OTB-0701
• Study Type: interventional
• Target: 127
• Locations: 4 countries
• Sites: 13

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Time to relapse in double-blind treatment phase

  throughout the study

Secondary Outcomes (3)

• Mean change from baseline to all time point in YMRS total score;

  throughout the study

• Mean change from baseline to all time points in MADRS total score

  throughout the study

• Response rate (≥ 50% improvement in YMRS total score) at all time points

  throughout the study

Study Arms (2)

1

EXPERIMENTAL

Drug: aripiprazole; Drug: valproate

2

PLACEBO COMPARATOR

Drug: valproate; Drug: placebo

Interventions

aripiprazole DRUG

15-30 mg/day aripiprazole, 22 weeks

Also known as: Abilify

1

valproate DRUG

sufficient dose as determined by investigator to maintain the therapeutic level.

1; 2

placebo DRUG

placebo to aripiprazole, 22 weeks

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• Platelets ≤ 75000/mm3
• Hemoglobin ≤ 9g/dL
• Neutrophils, absolute ≤ 1000/ mm3

Sponsors & Collaborators

• Korea Otsuka International Asia Arab: lead

Study Sites (13)

Castle Peak Hospital

Tuenmen, Hong Kong

Location

National Center for Mental Health

Mandaluyong, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

University of Sto. Tomas Hospital

Manila, Philippines

Location

Veterans Medical Memorial Center

Quezon, Philippines

Location

Changhua Chrisitian Hospital

Changhua, Taiwan

Location

Tsao-Tun Psychiatric Center

Nantou City, Taiwan

Location

Jia-Nan Mental Hospital

Tainan, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Taoyuan Mental Hospital

Taoyuan District, Taiwan

Location

Siriraj Hospital

Bangkok, Thailand

Location

Somdej Chaophraya Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Aripiprazole; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Nan-Ying Chiu, MD

  Changhua Christian Hospital, Taiwan

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2012
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

PH (4); HK (1); TW (6); TH (2)