Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Phase 2

Terminated

• Conditions: Depression
• Interventions: Drug: EVT 101; Drug: Placebo

• Registration Number: NCT01128452
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Study Start: 2010-06
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Disposition First Submitted: 2014-08-27
• Disposition First Submitted QC: 2014-08-27
• Disposition First Posted: 2014-08-28
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVT 101	EVT 101	EVT 101
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Profile of EVT 101	28 days of EVT 101-Treatment	AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who respond to treatment with study drug	4 weeks
Efficacy of EVT 101 in depression measured using the MADRS score	28 days	Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline
Percentage of patients who experience remission	4 weeks

Trial Locations

Locations (14)

Evotec Study Site 1; 🇺🇸 Baltimore, Maryland, United States

Evotec Study Site 12; 🇺🇸 Houston, Texas, United States

Evotec Study Site 2; 🇺🇸 Oak Brook, Illinois, United States

Evotec Study Site 15; 🇺🇸 Tampa, Florida, United States

Evotec Study Site 6; 🇺🇸 Oceanside, California, United States

Evotec Study Site 13; 🇺🇸 Oklahoma City, Oklahoma, United States

Evotec Study Site 4; 🇺🇸 Atlanta, Georgia, United States

Evotec Study Site 19; 🇺🇸 San Diego, California, United States

Evotec Study Site 7; 🇺🇸 Dallas, Texas, United States

Evotec Study Site 3; 🇺🇸 Beachwood, Illinois, 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 14; 🇺🇸 Smyrna, Georgia, United States