Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Status:	Terminated
Conditions:	Depression
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 55
Updated:	4/21/2016
Start Date:	June 2010
End Date:	March 2011

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

We found this trial at

sites

Evotec Study Site 14

Smyrna, Georgia

from

Smyrna, GA