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

December 15, 2020 updated by: Novartis

A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks

This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

644

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Novartis Investigative Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Novartis Investigative Site
      • Tucson, Arizona, United States, 85724
        • Novartis Investigative Site
    • California
      • Beverly Hills, California, United States, 90210
        • Novartis Investigative Site
      • Costa Mesa, California, United States, 92626
        • Novartis Investigative Site
      • Encino, California, United States, 91316
        • Novartis Investigative Site
      • Glendale, California, United States, 91206
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90024
        • Novartis Investigative Site
      • Newport Beach, California, United States, 92660
        • Novartis Investigative Site
      • Oceanside, California, United States, 92056
        • Novartis Investigative Site
      • Sacramento, California, United States, 95817
        • Novartis Investigative Site
      • Sherman Oaks, California, United States, 91403
        • Novartis Investigative Site
      • Temecula, California, United States, 92591
        • Novartis Investigative Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Novartis Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Novartis Investigative Site
      • Coral Springs, Florida, United States, 33065
        • Novartis Investigative Site
      • Fort Myers, Florida, United States, 33912
        • Novartis Investigative Site
      • Gainesville, Florida, United States, 32607
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
      • Saint Petersburg, Florida, United States, 33702
        • Novartis Investigative Site
      • Venice, Florida, United States, 34285
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33407
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Novartis Investigative Site
      • Chicago, Illinois, United States, 60640
        • Novartis Investigative Site
      • Libertyville, Illinois, United States, 60048
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Novartis Investigative Site
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
        • Novartis Investigative Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novartis Investigative Site
      • Towson, Maryland, United States, 21204
        • Novartis Investigative Site
      • Towson, Maryland, United States, 85724
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Novartis Investigative Site
      • Braintree, Massachusetts, United States, 02184
        • Novartis Investigative Site
      • Worcester, Massachusetts, United States, 01605
        • Novartis Investigative Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Novartis Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Novartis Investigative Site
      • Kansas City, Missouri, United States, 66160
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63033
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63044
        • Novartis Investigative Site
      • Saint Louis, Missouri, United States, 63118
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Novartis Investigative Site
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10467
        • Novartis Investigative Site
      • Buffalo, New York, United States, 14215
        • Novartis Investigative Site
      • New York, New York, United States, 10029
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Novartis Investigative Site
      • Raleigh, North Carolina, United States, 27609
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43210
        • Novartis Investigative Site
      • Toledo, Ohio, United States, 43623
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Novartis Investigative Site
      • Portland, Oregon, United States, 97239
        • Novartis Investigative Site
      • Rhododendron, Oregon, United States, 97049
        • Novartis Investigative Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Novartis Investigative Site
      • Lansdale, Pennsylvania, United States, 19446
        • Novartis Investigative Site
      • Philadelphia, Pennsylvania, United States, 19139
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15238
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Novartis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Novartis Investigative Site
      • Nashville, Tennessee, United States, 37212
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78754
        • Novartis Investigative Site
      • Austin, Texas, United States, 78756
        • Novartis Investigative Site
      • DeSoto, Texas, United States, 75115
        • Novartis Investigative Site
      • Houston, Texas, United States, 77030
        • Novartis Investigative Site
      • Houston, Texas, United States, 77007
        • Novartis Investigative Site
      • Houston, Texas, United States, 77042
        • Novartis Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Novartis Investigative Site
      • Virginia Beach, Virginia, United States, 23230
        • Novartis Investigative Site
    • Washington
      • Edmonds, Washington, United States, 98026
        • Novartis Investigative Site
      • Seattle, Washington, United States, 98104
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Novartis Investigative Site
      • West Allis, Wisconsin, United States, 53227
        • 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:

  • Male and female adults, 18 through 70 years of age, inclusive
  • Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
  • A history of at least two previous episodes of Major Depression plus the current episode
  • Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline

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
  • Use of any psychoactive medication after the screening visit
  • Patients who have been previously treated with 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: Prevention
  • 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
Time to relapse, where relapse is defined by the occurrence of any one of the following:
Time Frame: Primary efficacy variable is measured from randomization to relapse
Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
Time Frame: Primary efficacy variable is measured from randomization to relapse
Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;
Time Frame: Primary efficacy variable is measured from randomization to relapse
Primary efficacy variable is measured from randomization to relapse
suicide attempt or suicide;
Time Frame: Primary efficacy variable is measured from randomization to relapse
Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.
Time Frame: Primary efficacy variable is measured from randomization to relapse
Primary efficacy variable is measured from randomization to relapse

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale.
Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients experiencing relapse during the double-blind continuation phase.
Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D.
Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.
Time Frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase

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

April 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

April 30, 2007

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

  • CAGO178A2304

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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