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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00411242 |
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.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder (MDD) |
Drug: agomelatine Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 490 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: agomelatine |
2: Experimental | Drug: agomelatine |
3: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAGO178A2302 |
Study First Received: | December 11, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00411242 History of Changes |
Health Authority: | United States: Food and Drug Administration |
agomelatine, major depressive disorder, MDD, depression |
S 20098 Depression Mental Disorders Hypnotics and Sedatives Mood Disorders |
Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Depression Disease Physiological Effects of Drugs Central Nervous System Depressants Depressive Disorder, Major Depressive Disorder Pharmacologic Actions Behavioral Symptoms |
S 20098 Pathologic Processes Mental Disorders Therapeutic Uses Hypnotics and Sedatives Mood Disorders Central Nervous System Agents |