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COMPLETEDPHASE3

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

An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)

NCT01110889•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
•Current episode ≥4 weeks.
•CGI-Severity score ≥4 at Screening and Baseline.

Exclusion Criteria

•History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
•Any other current Axis I disorder other than MDD 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.
•Prior exposure to agomelatine.
•Female patients of childbearing potential who are not using effective contraception.

Locations (48)

Birmingham Psychiatry

Birmingham, Alabama, United States

Southwestern Research Institute

Beverly Hills, California, United States

Pharmacology Research Institute

Encino, California, United States

Mood & Anxiety Research

Fresno, California, United States

Excell Research, Inc

Oceanside, California, United States

Cnri-La, Llc

Pico Rivera, California, United States

CNRI San Diego

San Diego, California, United States

University of California San Diego Medical Center

San Diego, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Western Affiliated Research Institute

Denver, Colorado, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

July 1, 2011

Last Updated

December 23, 2020

Enrollment

582

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Agomelatine (AGO178C)

DRUG

Agomelatine (AGO178C)

DRUG

Placebo

DRUG

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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 Sublingual Tablets in the Treatment of Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

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