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

December 15, 2020 updated by: Novartis

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

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
        • Novartis Investigative Site
      • Rio Piedras, Puerto Rico
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Novartis Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novartis Investigative Site
    • California
      • Cerritos, California, United States, 90703
        • Novartis Investigative Site
      • El Centro, California, United States, 92243
        • Novartis Investigative Site
      • Garden Grove, California, United States, 92845
        • Novartis Investigative Site
      • Irvine, California, United States, 92618
        • Novartis Investigative Site
      • Lafayette, California, United States, 94549
        • Novartis Investigative Site
      • San Diego, California, United States, 92126
        • Novartis Investigative Site
      • Temecula, California, United States, 92591
        • Novartis Investigative Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Novartis Investigative Site
      • Hamden, Connecticut, United States, 06518
        • Novartis Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
      • Maitland, Florida, United States, 32751
        • Novartis Investigative Site
      • Port Charlotte, Florida, United States, 33952
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Novartis Investigative Site
      • Atlanta, Georgia, United States, 30329
        • Novartis Investigative Site
      • Marietta, Georgia, United States, 30060
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Novartis Investigative Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novartis Investigative Site
      • Salisbury, Maryland, United States, 21801
        • Novartis Investigative Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Novartis Investigative Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Novartis Investigative Site
      • Rochester Hills, Michigan, United States, 48307
        • Novartis Investigative Site
    • Missouri
      • Saint Peters, Missouri, United States, 63376
        • Novartis Investigative Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novartis Investigative Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Novartis Investigative Site
      • Dayton, Ohio, United States, 45408
        • Novartis Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Novartis Investigative Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78754
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75231
        • Novartis Investigative Site
      • Houston, Texas, United States, 77007
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novartis Investigative Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Novartis Investigative Site
    • Virginia
      • Midlothian, Virginia, United States, 23112
        • Novartis Investigative Site
    • Washington
      • Bothell, Washington, United States, 98011
        • Novartis Investigative Site

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:

  • 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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: agomelatine
Experimental: 2
Drug: agomelatine
Placebo Comparator: 3
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
Time Frame: 8 weeks
8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
Time Frame: 8 weeks
8 weeks
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
Time Frame: 8 weeks
8 weeks
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Novartis

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

December 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 13, 2006

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAGO178A2301

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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