SMART-A: Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness
Study Details
Study Description
Brief Summary
To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with Depakote(divalproate) in the acute phase of 6-week treatment 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
Outcome Measures
Primary Outcome Measures
- Changes in the YMRS total score from baseline to the end of 6-week study [Throughout the study]
Secondary Outcome Measures
- Changes in YMRS total scores from baseline to the end of 6-week study [Throughout the study]
Eligibility Criteria
Criteria
Inclusion Criteria:
Inclusion Criteria:
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Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
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The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20.
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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)
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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
Exclusion Criteria:
- Patients with the following clinical symptoms diagnosed using DSM-IV:
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Delirium, dementia, amnestic or other cognitive disorders
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Schizophrenia or schizoaffective disorder
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Patients who do not respond to clozapine
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Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
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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 Ablify(aripiprazole) or other quinolinones
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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
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Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
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Patients with vital sign or ECG results in the clinically significant abnormal laboratory test 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 given psychotropic medications (except benzodiazepines) one day before baseline visit
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Patients treated with Fluoxetine for the last 4 weeks
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Patients who participated in clinical trials with other investigational drugs for the last one month
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Patients with the history of convulsive disorder
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Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
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-0701