Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression

This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.

Inclusion Criteria:

• Major Depressive Disorder
• Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
• Has as score of >/= 18 on the Ham-D-17

Exclusion Criteria:

• Pregnant or breast-feeding women
• Evidence of age-related cognitive decline or mild dementia
• At imminent risk of committing suicide
• Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
• Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
• Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening