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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01110902

Public ClinicalTrials.gov record NCT01110902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01110902
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
589 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2010
Primary completion
May 31, 2011
Completion
May 31, 2011
Last update posted
Dec 23, 2020

2010 – 2011

United States locations

U.S. sites
43
U.S. states
22
U.S. cities
42
Facility City State ZIP Site status
University of Alabama at Birmingham, Department of Psychiatry Birmingham Alabama 35294
ATP Clinical Research Costa Mesa California 92626
Valley Clinical Research El Centro California 92243
Collaborative Neuroscience Network Garden Grove California 92845
University of California, Irvine Medical Center Orange California 92868
Anderson Clinical Research Redlands California 92374
Affiliated Research Institute San Diego California 92108
California Neuroscience Research Medical Group, Inc. Sherman Oaks California 91403
Viking Clinical Research Temecula California 92591
ICSL Clinical Studies Altamonte Springs Florida 32701
Florida Clinical Research Center, LLC Bradenton Florida 34208
Arocha Research Center Coral Gables Florida 33134
Innova Clinical Trials Miami Florida 33145
Miami Research Associates South Miami Florida 33143
Emory University Atlanta Georgia 30306
Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois 60169
Joliet Center for Clinical Research Joliet Illinois 60435
CNS Clinical Trials Park Ridge Illinois 60068
Deaconess Clinic Evansville Indiana 47713
Heartland Research Associates, LLC Wichita Kansas 67207
Pharmasite Research Pikesville Maryland 21208
Massachusetts General Hospital Boston Massachusetts 02114
Boston Clinical Trials Brighton Massachusetts 02135
Mercy Health Research St Louis Missouri 63141
Premier Psychiatry Group, LLC Lincoln Nebraska 68510
CRI Worldwide, LLC - Lourdes Division Willingboro New Jersey 08046
Social Psychiatric Research Institute Brooklyn New York 11235
Eastside Comprehensive Medical Service New York New York 10021
Neurobehavioral Clinical Research Canton Ohio 44718
University of Cincinnati Medical Center Cincinnati Ohio 45219
Neurology & Neuroscience Center of Ohio Toledo Ohio 43623
SP Research Oklahoma City Oklahoma 73112
Willamette Valley Clinical Studies Eugene Oregon 97404
Summit Research Network Portland Oregon 97210
CRI Worldwide, LLC - Kirkbride Division Philadelphia Pennsylvania 19139
Medical University of South Carolina North Charleston South Carolina 29406
CNS Healthcare Memphis Tennessee 38119
Research Strategies Memphis Tennessee 38119
FutureSearch Trials Austin Texas 78731
Claghorn-Lesem Research Clinic, Inc. Houston Texas 77008
University of Utah, Department of Psychiatry Salt Lake City Utah 84132
Northwest Clinical Research Center Bellevue Washington 98007
Summit Research Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01110902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 23, 2020 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01110902 live on ClinicalTrials.gov.

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