- Primary diagnosis of DSM-IV Major Depressive Disorder, single episode or recurrent,
without psychotic features. Additional DSM-IV Axis I diagnoses will be permitted only
if they are identified as secondary diagnoses.
- Hamilton-Depression rating scale (HAM-D; 17 item) total score ≥18 and HAMD item 1
(depressed mood) score ≥2.
- Use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- Current or past diagnosis of bipolar disorder or any psychotic disorder.