Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Janssen (J&J Innovative Medicine)

Status and phase

Terminated

Phase 2

Conditions

Depression

Treatments

Drug: Placebo

Drug: EVT 101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01128452

RRA-12001, EVT 101/1012 (Other Identifier)

CR104589

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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