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

Last updated: December 15, 2020
Sponsor: Novartis
Overall Status: Completed

Phase

3

Condition

Depression

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT00411099
CAGO178A2301
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder, single or recurrent episode, according toDSM-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 theOpen-Label Extension Phase

Exclusion

Exclusion Criteria:

  • History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eatingdisorder, or obsessive compulsive disorder
  • Any current Axis I disorder other than major depressive disorder which is the focus oftreatment
  • 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 Design

Total Participants: 508
Study Start date:
December 01, 2006
Estimated Completion Date:

Connect with a study center

  • Novartis Investigative Site

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Rio Piedras,
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Novartis Investigative Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Novartis Investigative Site

    Cerritos, California 90703
    United States

    Site Not Available

  • Novartis Investigative Site

    El Centro, California 92243
    United States

    Site Not Available

  • Novartis Investigative Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Novartis Investigative Site

    Irvine, California 92618
    United States

    Site Not Available

  • Novartis Investigative Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Novartis Investigative Site

    San Diego, California 92126
    United States

    Site Not Available

  • Novartis Investigative Site

    Temecula, California 92591
    United States

    Site Not Available

  • Novartis Investigative Site

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Novartis Investigative Site

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Novartis Investigative Site

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Novartis Investigative Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novartis Investigative Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • Novartis Investigative Site

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Novartis Investigative Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Novartis Investigative Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Novartis Investigative Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Novartis Investigative Site

    Salisbury, Maryland 21801
    United States

    Site Not Available

  • Novartis Investigative Site

    Pittsfield, Massachusetts 01201
    United States

    Site Not Available

  • Novartis Investigative Site

    Farmington Hills, Michigan 48336
    United States

    Site Not Available

  • Novartis Investigative Site

    Rochester Hills, Michigan 48307
    United States

    Site Not Available

  • Novartis Investigative Site

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • Novartis Investigative Site

    St. Peters, Missouri 63376
    United States

    Site Not Available

  • Novartis Investigative Site

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Novartis Investigative Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Novartis Investigative Site

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Novartis Investigative Site

    New York, New York 10021
    United States

    Site Not Available

  • Novartis Investigative Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Novartis Investigative Site

    Dayton, Ohio 45408
    United States

    Site Not Available

  • Novartis Investigative Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Novartis Investigative Site

    Eugene, Oregon 97404
    United States

    Site Not Available

  • Novartis Investigative Site

    N. Charleston, South Carolina 29406
    United States

    Site Not Available

  • Novartis Investigative Site

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Novartis Investigative Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Novartis Investigative Site

    Austin, Texas 78754
    United States

    Site Not Available

  • Novartis Investigative Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77007
    United States

    Site Not Available

  • Novartis Investigative Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Novartis Investigative Site

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Novartis Investigative Site

    Midlothian, Virginia 23112
    United States

    Site Not Available

  • Novartis Investigative Site

    Bothell, Washington 98011
    United States

    Site Not Available

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