Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

Inclusion Criteria: * 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 Exclusion Criteria: * 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