Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression

This double-blind, placebo-control, fixed dose, randomized study will be conducted at a tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited into the groups. The study group of patients will receive ten weeks of treatment with a combination of fix-dosed sertraline and aripiprazole. The control group will received sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and aripiprazole.

Inclusion criteria

• Male or female subjects 18 to 65 years inclusive.
• Fulfilled DSM-Ⅳ criteria for major depressive disorder.
• Onset ≧2 weeks.
• Baseline score ≧14 on the HAM-D17.
• Written informed consent prior to entry into the study.

Exclusion criteria

• HAM-D17 item 3 score≧3.
• Life-time history of bipolar disorders, schizophrenia or schizoaffective disorder.
• Current history of panic disorder, obsessive-compulsive disorder, alcohol or substance abuse.
• Mood disorder due to general medical condition.
• Treatment with antidepressants at entry into the study before 2 weeks.
• Need for psychoactive medications other than the study drugs, except for one benzodiazepine or hypnotic given at a stable dose.
• Known intolerance or inefficacy to either drug.
• Previous lack of response to two or more antidepressants at adequate dosage.
• Subjects who have acute or unstable medical illness or organic failure.
• Pregnancy and breast-feeding.