Abilify in Bipolar Disorder for 6 Weeks Treatment Effectiveness

Further study details as provided by Korea OIAA

Inclusion criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.