Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
NCT ID: NCT01128452
Last Updated: 2016-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2010-06-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
HPMC Placebo capsules, once daily for 28 days
EVT 101
EVT 101
EVT 101
HPMC Capsule, 15 mg, once daily for 28 days
Interventions
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EVT 101
HPMC Capsule, 15 mg, once daily for 28 days
Placebo
HPMC Placebo capsules, once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Doris Greiling, PhD
Role: STUDY_DIRECTOR
Evotec AG
Locations
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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
Countries
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Other Identifiers
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RRA-12001, EVT 101/1012
Identifier Type: OTHER
Identifier Source: secondary_id
CR104589
Identifier Type: -
Identifier Source: org_study_id
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