Abilify in Bipolar Disorder for 24 Weeks Treatment Effectiveness

Further study details as provided by Korea OIAA

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
• 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
• 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
• 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