Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)
Launched by NOVARTIS PHARMACEUTICALS · Apr 26, 2010
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- • Current episode ≥4 weeks.
- • CGI-Severity score ≥4 at Screening and Baseline.
- Exclusion Criteria:
- • History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
- • Any other current Axis I disorder other than MDD 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.
- • Prior exposure to agomelatine.
- • Female patients of childbearing potential who are not using effective contraception.
- • Other protocol-defined inclusion/exclusion criteria may apply
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Boston, Massachusetts, United States
North Charleston, South Carolina, United States
Orange, California, United States
Cincinnati, Ohio, United States
Wichita, Kansas, United States
Redlands, California, United States
Memphis, Tennessee, United States
Garden Grove, California, United States
Sherman Oaks, California, United States
Portland, Oregon, United States
Toledo, Ohio, United States
Atlanta, Georgia, United States
South Miami, Florida, United States
El Centro, California, United States
Temecula, California, United States
Costa Mesa, California, United States
Eugene, Oregon, United States
Evansville, Indiana, United States
Bradenton, Florida, United States
Hoffman Estates, Illinois, United States
Houston, Texas, United States
Saint Louis, Missouri, United States
Bellevue, Washington, United States
Oklahoma City, Oklahoma, United States
Joliet, Illinois, United States
Austin, Texas, United States
Birmingham, Alabama, United States
Altamonte Springs, Florida, United States
Coral Gables, Florida, United States
Miami, Florida, United States
Park Ridge, Illinois, United States
Pikesville, Maryland, United States
Brighton, Massachusetts, United States
Lincoln, Nebraska, United States
Willingboro, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
Canton, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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