Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT01128452

Run by

Janssen Research & Development, LLC

People needed

8

Starts

2010-06-01

Expected to finish

2011-03-01

Last updated by the study team

2016-03-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Evotec Study Site 6 — Oceanside, California, United States
• Evotec Study Site 19 — San Diego, California, United States
• Evotec Study Site 15 — Tampa, Florida, United States
• Evotec Study Site 4 — Atlanta, Georgia, United States
• Evotec Study Site 14 — Smyrna, Georgia, United States
• Evotec Study Site 3 — Beachwood, Illinois, United States
• Evotec Study Site 2 — Oak Brook, Illinois, United States
• Evotec Study Site 1 — Baltimore, Maryland, United States
• Evotec Study Site 8 — Flowood, Mississippi, United States
• Evotec Study Site 5 — Willingboro, New Jersey, United States
• Evotec Study Site 9 — New York, New York, United States
• Evotec Study Site 13 — Oklahoma City, Oklahoma, United States
• Evotec Study Site 7 — Dallas, Texas, United States
• Evotec Study Site 12 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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