SA4503 8-Week Study in Major Depressive Disorder (MDD)

Further study details as provided by M's Science Corporation:

Inclusion criteria

• Male or female between the ages of 18 and 65 (inclusive)
• Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
• HAM-D17 score of >/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
• Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.

Exclusion criteria

• Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
• Subjects who require psychotropic medication other than the study medication
• Subjects who started psychotherapy within 4 months prior to Screening
• Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
• Subjects who have a primary diagnosis of anxiety
• Subjects who regularly use sleeping medication more than 3 times per week
• Subjects who have major psychiatric or neurologic disorders other than MDD
• Subjects with depression secondary to stroke, cancer, or other severe medical illness
• Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)