Bipolar DisorderPhase 4SMART-MNCT00545675
Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness
A Phase 4 study testing Abilify(aripiprazole) and Depakote (divalproate) in people with Bipolar Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar disorder 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?
- Abilify(aripiprazole) and Depakote (divalproate)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Jul 2010
- 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
- Mania or mixed episode of bipolar disorder according to DSM-IV
- Male and female between the age of 18 and 65 (In case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. Pregnant and breast-feeding women cannot be included)
- Patients who can consent to participate in this clinical trial
- Patients who understand this trial and comply with all protocol requirements
- Patients who fulfill the following remission criteria for bipolar disorder in the two consecutive evaluation performed every week at Week 6 of 6-week study and thereafter:
- (Definition of remission: a score less than 12 on the YMRS total score and simultaneously a score less than 13 on the MADRS total score)
Who cannot join
- Patients with the following clinical symptoms diagnosed using DSM-1. Patients with the following clinical symptoms diagnosed using DSM-IV:
- Delirium, dementia, amnestic or other cognitive disorders
- Schizophrenia or schizoaffective disorder
- Patients who do not respond to clozapine
- Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
- Patients diagnosed with substance-related disorder according to DSM-IV within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). The abuse of benzodiazepines is included with the exception of caffeine or nicotine.
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- Patients known to have allergy or hypersensitivity reaction to Abilify(aripiprazole) or other quinolinones
- Patients at high risk of suicide attempt or with the history of murder or mental status test
- Patients with the history of neuroleptic malignant syndrome
- Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
- Patients with clinically significantly abnormal laboratory results, vital sign or ECG results
- Pregnant women or child-bearing women who do not or cannot use appropriate contraception
- Patients with the history of convulsive disorder
- Patients judged to have decreased compliance to the investigational drugs during a 6-week trial period by an investigator
- Patients who commit serious protocol violation during a 6-week trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Double-blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify and Depakote in 24-week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-week Treatment With Abilify and Depakote
To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar disorder
Read the detailed description
Further study details as provided by Korea OIAA
- Conditions
- Bipolar Disorder
- Being tested
- Abilify(aripiprazole), Depakote (divalproate)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abilify(aripiprazole)Drug
Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
Depakote (divalproate)Drug
Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Abilify(aripiprazole) + Depakote(divalproate) Receives: Drug: Abilify(aripiprazole) |
| 2 | Placebo comparator | Divalproate + Placebo Receives: Drug: Depakote (divalproate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of bipolar disorder from randomization
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 posted17 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2010
- Study completionJul 2010
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
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Won-Myong Bahk, MD, Principal investigator, St Mary's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545675
- Sponsor's protocol ID
- 031-KOB-0702
- Acronym
- SMART-M
- Status last verified
- Dec 2009
- First submitted
- 16 Oct 2007
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify and Depakote in 24-week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-week Treatment With Abilify and Depakote
- ClinicalTrials.gov ID
- NCT00545675
- Acronym / sponsor ID
- SMART-M / 031-KOB-0702
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Oct 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 demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar disorder
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: Abilify(aripiprazole)Abilify(aripiprazole) + Depakote(divalproate) |
| 2 | Placebo comparator | Drug: Depakote (divalproate)Divalproate + Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mania or mixed episode of bipolar disorder according to DSM-IV
- Male and female between the age of 18 and 65 (In case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. Pregnant and breast-feeding women cannot be included)
- Patients who can consent to participate in this clinical trial
- Patients who understand this trial and comply with all protocol requirements
- Patients who fulfill the following remission criteria for bipolar disorder in the two consecutive evaluation performed every week at Week 6 of 6-week study and thereafter:
Key exclusion criteria (15 listed)
- Patients with the following clinical symptoms diagnosed using DSM-1. Patients with the following clinical symptoms diagnosed using DSM-IV:
- Patients who do not respond to clozapine
- Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
- Patients diagnosed with substance-related disorder according to DSM-IV within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). The abuse of benzodiazepines is included with the exception of caffeine or nicotine.
- Patients known to have allergy or hypersensitivity reaction to Abilify(aripiprazole) or other quinolinones
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 |
|---|---|---|
| Abilify(aripiprazole)Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder | Drug | 1 |
| Depakote (divalproate)Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder | Drug | 2 |
Primary outcome
Time to recurrence of bipolar disorder from randomization
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 12 Aug 2010.
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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.
Won-Myong Bahk, MD principal investigator
St Mary's Hospital, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abilify(aripiprazole) and Depakote (divalproate) in people with Bipolar Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
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 6 inclusion and 15 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 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 recurrence of bipolar disorder from randomization (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 12 Aug 2010.