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Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)

NCT00411099•Novartis

View on ClinicalTrials.gov

Summary

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
•HAM-D17 total score \> or = 22 at Screening and Baseline
•CGI-Severity score \> or = 4 at Screening and Baseline
•Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase

Exclusion Criteria

•History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
•Any current Axis I disorder other than major depressive disorder which is the focus of treatment
•Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
•Concomitant psychotropic medication, including herbal preparations and melatonin
•Psychotherapy of any type
•Female patients of childbearing potential who are not using effective contraception

Locations (44)

Novartis Investigative Site

Scottsdale, Arizona, United States

Novartis Investigative Site

Little Rock, Arkansas, United States

Novartis Investigative Site

Cerritos, California, United States

Novartis Investigative Site

El Centro, California, United States

Novartis Investigative Site

Garden Grove, California, United States

Novartis Investigative Site

Irvine, California, United States

Novartis Investigative Site

Lafayette, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Temecula, California, United States

Novartis Investigative Site

Cromwell, Connecticut, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

January 1, 2008

Last Updated

December 23, 2020

Enrollment

508

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

agomelatine

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: December 23, 2020Data 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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Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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

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Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression