Bipolar DisorderPhase 4ABLENCT00484471
ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness
A Phase 4 study testing aripiprazole and valproate in people with Bipolar Disorder, run by Korea Otsuka International Asia Arab at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- aripiprazole and valproate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Oct 2007to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
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- 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.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Taiwan6 sites
Changhua Chrisitian Hospital
Changhua
Tsao-Tun Psychiatric Center
Nantou City
Jia-Nan Mental Hospital
Tainan
National Cheng-Kung University Hospital
Tainan
Tri-Service General Hospital
Taipei
Taoyuan Mental Hospital
Taoyuan
Philippines4 sites
National Center for Mental Health
Mandaluyong
Philippine General Hospital
Manila
University of Sto. Tomas Hospital
Manila
Veterans Medical Memorial Center
Quezon
About this study
Official title: 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.
Read the detailed description
Further study details as provided by Korea OIAA
- Conditions
- Bipolar Disorder
- Being tested
- aripiprazole, valproate, placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
15-30 mg/day aripiprazole, 22 weeks
valproateDrug
sufficient dose as determined by investigator to maintain the therapeutic level.
placeboDrug
placebo to aripiprazole, 22 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: aripiprazole; Drug: valproate |
| 2 | Placebo comparator | Not described Receives: Drug: valproate; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse in double-blind treatment phase
Measured: throughout the study
Secondary outcomes (3)
Mean change from baseline to all time point in YMRS total score;
Measured: throughout the study
Mean change from baseline to all time points in MADRS total score
Measured: throughout the study
Response rate (≥ 50% improvement in YMRS total score) at all time points
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka International Asia Arab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan-Ying Chiu, MD, Study chair, Changhua Christian Hospital, TaiwanHun-Yu Chang, MD, Principal investigator, Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. TaiwanYen-Kung Yang, MD, Principal investigator, National Cheng-Kung University HospitalWen-Chen Ouyang, MD, Principal investigator, Jia-Nan Mental HospitalWei-Wen Lin, MD, Principal investigator, Tri-Service General Hospital (TSGH)Tso-Ren Wang, MD, Principal investigator, Tsao-Tun Psychistric CenterEfren Reyes, MD, Principal investigator, National Center for Mental Health (NCMH)Rosanna de Guzman, MD, Principal investigator, Philippine General Hospital (PGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484471
- Sponsor's protocol ID
- 031-OTB-0701
- Acronym
- ABLE
- Status last verified
- Mar 2022
- First submitted
- 8 Jun 2007
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00484471
- Acronym / sponsor ID
- ABLE / 031-OTB-0701
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Korea Otsuka International Asia ArabIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: aripiprazole, Drug: valproate |
| 2 | Placebo comparator | Drug: valproate, Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aripiprazoleAlso: Abilify15-30 mg/day aripiprazole, 22 weeks | Drug | 1 |
| valproatesufficient dose as determined by investigator to maintain the therapeutic level. | Drug | 1, 2 |
| placeboplacebo to aripiprazole, 22 weeks | Drug | 2 |
Primary outcome
Time to relapse in double-blind treatment phase
Time frame: throughout the study
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan-Ying Chiu, MD study chair
Changhua Christian Hospital, Taiwan
Hun-Yu Chang, MD principal investigator
Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
Yen-Kung Yang, MD principal investigator
National Cheng-Kung University Hospital
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aripiprazole and valproate in people with Bipolar Disorder, run by Korea Otsuka International Asia Arab at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Taiwan, Philippines, Thailand, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse in double-blind treatment phase (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.