Study Stopped
Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
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
2 other identifiers
interventional
8
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 depression
Started Jun 2010
Shorter than P25 for phase_2 depression
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 28, 2016
March 1, 2016
9 months
May 19, 2010
March 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability Profile of EVT 101
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
28 days of EVT 101-Treatment
Secondary Outcomes (3)
Efficacy of EVT 101 in depression measured using the MADRS score
28 days
Percentage of patients who respond to treatment with study drug
4 weeks
Percentage of patients who experience remission
4 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
EVT 101
EXPERIMENTALEVT 101
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Hoffmann-La Rochecollaborator
Study Sites (14)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Doris Greiling, PhD
Evotec AG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 21, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 28, 2016
Record last verified: 2016-03