Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Phase 2TerminatedNCT01128452

Janssen Research & Development, LLC8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression

Interventions

EVT 101DRUG

HPMC Capsule, 15 mg, once daily for 28 days

PlaceboDRUG

HPMC Placebo capsules, once daily for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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

Time frame: 28 days of EVT 101-Treatment

Secondary Outcomes

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

Time frame: 28 days

Percentage of patients who respond to treatment with study drug

Time frame: 4 weeks

Percentage of patients who experience remission

Time frame: 4 weeks

Data from ClinicalTrials.gov

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