- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467402
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
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Alabama
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Birmingham, Alabama, United States, 35226
- Novartis Investigative Site
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Arizona
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Peoria, Arizona, United States, 85381
- Novartis Investigative Site
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Tucson, Arizona, United States, 85724
- Novartis Investigative Site
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California
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Beverly Hills, California, United States, 90210
- Novartis Investigative Site
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Costa Mesa, California, United States, 92626
- Novartis Investigative Site
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Encino, California, United States, 91316
- Novartis Investigative Site
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Glendale, California, United States, 91206
- Novartis Investigative Site
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Los Angeles, California, United States, 90024
- Novartis Investigative Site
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Newport Beach, California, United States, 92660
- Novartis Investigative Site
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Oceanside, California, United States, 92056
- Novartis Investigative Site
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Sacramento, California, United States, 95817
- Novartis Investigative Site
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Sherman Oaks, California, United States, 91403
- Novartis Investigative Site
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Temecula, California, United States, 92591
- Novartis Investigative Site
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Colorado
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Wheat Ridge, Colorado, United States, 80033
- Novartis Investigative Site
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Florida
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Bradenton, Florida, United States, 34208
- Novartis Investigative Site
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Coral Springs, Florida, United States, 33065
- Novartis Investigative Site
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Fort Myers, Florida, United States, 33912
- Novartis Investigative Site
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Gainesville, Florida, United States, 32607
- Novartis Investigative Site
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Jacksonville, Florida, United States, 32216
- Novartis Investigative Site
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Saint Petersburg, Florida, United States, 33702
- Novartis Investigative Site
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Venice, Florida, United States, 34285
- Novartis Investigative Site
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West Palm Beach, Florida, United States, 33407
- Novartis Investigative Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Novartis Investigative Site
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Illinois
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Chicago, Illinois, United States, 60611
- Novartis Investigative Site
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Chicago, Illinois, United States, 60640
- Novartis Investigative Site
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Libertyville, Illinois, United States, 60048
- Novartis Investigative Site
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Kansas
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Overland Park, Kansas, United States, 66211
- Novartis Investigative Site
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Topeka, Kansas, United States, 66606
- Novartis Investigative Site
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Louisiana
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New Orleans, Louisiana, United States, 70114
- Novartis Investigative Site
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Maryland
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Rockville, Maryland, United States, 20852
- Novartis Investigative Site
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Towson, Maryland, United States, 21204
- Novartis Investigative Site
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Towson, Maryland, United States, 85724
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, United States, 02135
- Novartis Investigative Site
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Braintree, Massachusetts, United States, 02184
- Novartis Investigative Site
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Worcester, Massachusetts, United States, 01605
- Novartis Investigative Site
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Michigan
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Farmington Hills, Michigan, United States, 48336
- Novartis Investigative Site
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- Novartis Investigative Site
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Missouri
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Kansas City, Missouri, United States, 64111
- Novartis Investigative Site
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Kansas City, Missouri, United States, 66160
- Novartis Investigative Site
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Saint Louis, Missouri, United States, 63033
- Novartis Investigative Site
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Saint Louis, Missouri, United States, 63044
- Novartis Investigative Site
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Saint Louis, Missouri, United States, 63118
- Novartis Investigative Site
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Nebraska
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Omaha, Nebraska, United States, 68198
- Novartis Investigative Site
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New Jersey
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Newark, New Jersey, United States, 07103
- Novartis Investigative Site
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Novartis Investigative Site
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New York
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Bronx, New York, United States, 10467
- Novartis Investigative Site
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Buffalo, New York, United States, 14215
- Novartis Investigative Site
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New York, New York, United States, 10029
- Novartis Investigative Site
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New York, New York, United States, 10021
- Novartis Investigative Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Novartis Investigative Site
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Raleigh, North Carolina, United States, 27609
- Novartis Investigative Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Novartis Investigative Site
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Columbus, Ohio, United States, 43210
- Novartis Investigative Site
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Toledo, Ohio, United States, 43623
- Novartis Investigative Site
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Oregon
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Portland, Oregon, United States, 97210
- Novartis Investigative Site
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Portland, Oregon, United States, 97239
- Novartis Investigative Site
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Rhododendron, Oregon, United States, 97049
- Novartis Investigative Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Novartis Investigative Site
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Lansdale, Pennsylvania, United States, 19446
- Novartis Investigative Site
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Philadelphia, Pennsylvania, United States, 19139
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, United States, 15213
- Novartis Investigative Site
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Pittsburgh, Pennsylvania, United States, 15238
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, United States, 29412
- Novartis Investigative Site
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Tennessee
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Memphis, Tennessee, United States, 38119
- Novartis Investigative Site
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Nashville, Tennessee, United States, 37212
- Novartis Investigative Site
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Texas
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Austin, Texas, United States, 78754
- Novartis Investigative Site
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Austin, Texas, United States, 78756
- Novartis Investigative Site
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DeSoto, Texas, United States, 75115
- Novartis Investigative Site
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Houston, Texas, United States, 77030
- Novartis Investigative Site
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Houston, Texas, United States, 77007
- Novartis Investigative Site
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Houston, Texas, United States, 77042
- Novartis Investigative Site
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Lake Jackson, Texas, United States, 77566
- Novartis Investigative Site
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Virginia
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Richmond, Virginia, United States, 23230
- Novartis Investigative Site
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Virginia Beach, Virginia, United States, 23230
- Novartis Investigative Site
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Washington
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Edmonds, Washington, United States, 98026
- Novartis Investigative Site
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Seattle, Washington, United States, 98104
- Novartis Investigative Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Novartis Investigative Site
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West Allis, Wisconsin, United States, 53227
- Novartis Investigative Site
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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 |
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Experimental: 1
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Experimental: 2
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Placebo Comparator: 3
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Primary efficacy variable is measured from randomization to relapse
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Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
Time Frame: Primary efficacy variable is measured from randomization to relapse
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Primary efficacy variable is measured from randomization to relapse
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hospitalization due to depression;
Time Frame: Primary efficacy variable is measured from randomization to relapse
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Primary efficacy variable is measured from randomization to relapse
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suicide attempt or suicide;
Time Frame: Primary efficacy variable is measured from randomization to relapse
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Primary efficacy variable is measured from randomization to relapse
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discontinuation due to lack of efficacy according to Investigator judgment.
Time Frame: Primary efficacy variable is measured from randomization to relapse
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Primary efficacy variable is measured from randomization to relapse
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
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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
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Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
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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
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Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
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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
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Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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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