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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 Oct 22, 2026, 2:12 AM 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
May 2010 (Type not available)
Primary completion
Jun 2011 (Actual)
Completion
Jun 2011 (Actual)
Last update posted
Dec 24, 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 24, 2020 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01110902 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →