SMART-M: Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Further study details as provided by Korea OIAA
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Abilify(aripiprazole) + Depakote(divalproate) |
Drug: Abilify(aripiprazole)
Abilify and Depakote in 24-week treatment of mania in patients with bipolar disorder
|
| Placebo Comparator: 2 Divalproate + Placebo |
Drug: Depakote (divalproate)
Placebo and Depakote in 24-week treatment of mania in patients with bipolar disorder
|
Outcome Measures
Primary Outcome Measures
- Time to recurrence of bipolar disorder from randomization [Throughout the study]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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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)
Exclusion Criteria:
- 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
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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.
-
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
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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
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Pregnant women or child-bearing women who do not or cannot use appropriate contraception
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Patients with the history of convulsive disorder
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Mary's Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Won-Myong Bahk, MD, St Mary's Hospital, London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 031-KOB-0702