Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Serge Beaulieu
With
Bristol-Myers Squibb
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age : 18-65
Male or female
Bipolar Disorder type I
Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
If female and of childbearing potential, is using an adequate method of contraception.
Is treated with a mood stabilizer (lithium and/or valproate)
Patient is able to give his consent
You may not be if
Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
Hypo(mania) episode with YMRS ≥ 8
Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
Is pregnant or lactating or absence of contraceptive treatment
Drug abuse or dependence as per DSM-IV (MINI)
Unstable medical condition
Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
Deficit in vitamin B12 or folate
Alcohol or drug abuse
Rapid cycling (more than 4 mood episodes per year)
Active or history of difficulty to swallow
Seizures not currently controlled with medications
Orthostatic hypotension
A history of clinically significant cardiovascular disorders and cardiac arrhythmias
A low white blood cell count
Known eye disease
Involuntary, irregular muscle movements, especially in the face
Known hypersensitivity to aripiprazole and any components of its formulation
Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose
