Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness (SMART-A)
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Multi-center, Single Arm, Open Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify With Depakote in the 6-week Treatment of Acute Mania in Patients With Bipolar Disorder
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than 20.
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 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.
Patients known to have allergy or hypersensitivity reaction to Ablify(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 vital sign or ECG results in the clinically significant abnormal laboratory test 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 given psychotropic medications (except benzodiazepines) one day before baseline visit
Patients treated with Fluoxetine for the last 4 weeks
Patients who participated in clinical trials with other investigational drugs for the last one month
Patients with the history of convulsive disorder
Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.