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

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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
14
sites
Flowood, Mississippi
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Flowood, MS
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Atlanta, Georgia
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Atlanta, GA
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Baltimore, Maryland
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Baltimore, MD
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Beachwood, Illinois
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Beachwood, IL
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Dallas, Texas
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Dallas, TX
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Houston, Texas
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Houston, TX
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New York, New York
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New York, NY
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Oak Brook, Illinois
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Oak Brook, IL
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Oceanside, California
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Oceanside, CA
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Oklahoma City, Oklahoma
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Oklahoma City, OK
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San Diego, California
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San Diego, CA
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Smyrna, Georgia
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Smyrna, GA
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Tampa, Florida
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Tampa, FL
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Willingboro, New Jersey
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Willingboro, NJ
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