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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
644

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: agomelatine
Experimental: 2
Drug: agomelatine
Placebo Comparator: 3
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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