Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: EVT 101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* HPMC Placebo capsules, once daily for 28 days<br>|
| Experimental: EVT 101<br>EVT 101 | Drug: EVT 101<br>* HPMC Capsule, 15 mg, once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment-Resistant Depression