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

December 16, 2020 updated by: Novartis Pharmaceuticals

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

589

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
        • Caribbean Research and Education Center
      • San Juan, Puerto Rico, 00907
        • Dharma Institute and Research Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham, Department of Psychiatry
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research
      • El Centro, California, United States, 92243
        • Valley Clinical Research
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
      • Temecula, California, United States, 92591
        • Viking Clinical Research
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • ICSL Clinical Studies
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC
      • Coral Gables, Florida, United States, 33134
        • Arocha Research Center
      • Miami, Florida, United States, 33145
        • Innova Clinical Trials
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory University
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Joliet, Illinois, United States, 60435
        • Joliet Center for Clinical Research
      • Park Ridge, Illinois, United States, 60068
        • CNS Clinical Trials
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • PharmaSite Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Brighton, Massachusetts, United States, 02135
        • Boston Clinical Trials
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Health Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Premier Psychiatry Group, LLC
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide, LLC - Lourdes Division
    • New York
      • Brooklyn, New York, United States, 11235
        • Social Psychiatric Research Institute
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Service
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neurobehavioral Clinical Research
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC - Kirkbride Division
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare
      • Memphis, Tennessee, United States, 38119
        • Research Strategies
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials
      • Houston, Texas, United States, 77008
        • Claghorn-Lesem Research Clinic, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, Department of Psychiatry
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Summit Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: AGO178C 0.5 mg /day
Drug: Agomelatine (AGO178C)
EXPERIMENTAL: AGO178C 1 mg / day
Drug: Agomelatine (AGO178C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
Time Frame: 8 weeks
8 weeks
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
Time Frame: 8 weeks
8 weeks
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
Time Frame: 8 weeks
8 weeks
Proportion of patients who achieve remission
Time Frame: 8 weeks
8 weeks
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (ESTIMATE)

April 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAGO178C2302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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