- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00411242
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 (CAGO178A2302E)
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)
503
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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Arizona
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Mesa, Arizona, United States, 85210
- Novartis Investigative Site
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California
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Los Angeles, California, United States, 90024
- Novartis Investigative Site
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Oceanside, California, United States, 92056
- Novartis Investigative Site
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San Diego, California, United States, 92123
- Novartis Investigative Site
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San Diego, California, United States, 92103
- Novartis Investigative Site
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San Diego, California, United States, 92108
- Novartis Investigative Site
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Colorado
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Denver, Colorado, United States, 80212
- Novartis Investigative Site
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Florida
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Daytona Beach, Florida, United States, 32124
- Novartis Investigative Site
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Fort Lauderdale, Florida, United States, 33319
- Novartis Investigative Site
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Miami, Florida, United States, 33143
- Novartis Investigative Site
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North Miami, Florida, United States, 33161
- Novartis Investigative Site
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North Miami, Florida, United States
- Novartis Investigative Site
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Orlando, Florida, United States, 32806
- Novartis Investigative Site
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Georgia
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Atlanta, Georgia, United States, 30328
- Novartis Investigative Site
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Smyrna, Georgia, United States, 30080
- Novartis Investigative Site
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Illinois
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Hoffman Estates, Illinois, United States, 60169
- Novartis Investigative Site
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Hoffman Estates, Illinois, United States, 60194
- Novartis Investigative Site
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Park Ridge, Illinois, United States, 60068
- Novartis Investigative Site
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Skokie, Illinois, United States, 60076
- Novartis Investigative Site
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Kansas
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Prairie Village, Kansas, United States, 66206
- Novartis Investigative Site
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Topeka, Kansas, United States, 66606
- Novartis Investigative Site
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Wichita, Kansas, United States, 67207
- Novartis Investigative Site
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Louisiana
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Shreveport, Louisiana, United States, 71103
- Novartis Investigative Site
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Maryland
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Glen Burnie, Maryland, United States, 21061
- Novartis Investigative Site
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Nevada
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Las Vegas, Nevada, United States, 89128
- Novartis Investigative Site
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New Jersey
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Kenilworth, New Jersey, United States, 07033
- Novartis Investigative Site
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Summit, New Jersey, United States, 07901
- Novartis Investigative Site
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Toms River, New Jersey, United States, 08755
- Novartis Investigative Site
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New York
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Brooklyn, New York, United States, 11201
- Novartis Investigative Site
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Cedarhurst, New York, United States, 11516
- Novartis Investigative Site
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Fresh Meadows, New York, United States, 11366
- Novartis Investigative Site
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New York, New York, United States, 10021
- Novartis Investigative Site
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New York, New York, United States, 10023
- Novartis Investigative Site
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Staten Island, New York, United States, 10312
- Novartis Investigative Site
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West Allis, New York, United States, 53227
- Novartis Investigative Site
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North Carolina
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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, 44122
- Novartis Investigative Site
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Toledo, Ohio, United States, 43623
- Novartis Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Novartis Investigative Site
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Oregon
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Medford, Oregon, United States, 97504
- Novartis Investigative Site
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Portland, Oregon, United States, 97210
- Novartis Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Novartis Investigative Site
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Tennessee
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Memphis, Tennessee, United States, 38119
- Novartis Investigative Site
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Texas
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Austin, Texas, United States, 78756
- Novartis Investigative Site
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Houston, Texas, United States, 77008
- Novartis Investigative Site
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Houston, Texas, United States, 77090
- Novartis Investigative Site
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Irving, Texas, United States, 75062
- Novartis Investigative Site
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Virginia
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Arlington, Virginia, United States, 22201
- Novartis Investigative Site
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Washington
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Bellevue, Washington, United States, 98004
- 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, 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:
- 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 |
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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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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
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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8 weeks
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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
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8 weeks
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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
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8 weeks
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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
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8 weeks
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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
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8 weeks
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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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAGO178A2302
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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