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Safety and Efficacy of EVT 101 in Treatment-Resistant Depression | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT01128452•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

June 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

March 28, 2016

Enrollment

ACTUAL participants

Conditions

Depression

Interventions

EVT 101

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

Inclusion Criteria

Exclusion Criteria

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A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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