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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00463242 |
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: agomelatine Drug: paroxetine Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week, Multicenter, Randomized, Double-Blind, Placebo- and Paroxetine-Controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-Week Open-Label Treatment With Agomelatine 25 or 50 mg |
Estimated Enrollment: | 490 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: agomelatine |
2: Active Comparator | Drug: paroxetine |
3: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CAGO178A2303 |
Study First Received: | April 19, 2007 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00463242 |
Health Authority: | United States: Food and Drug Administration |
agomelatine, Major Depressive Disorder, MDD, depression |
S 20098 Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Paroxetine Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Hypnotics and Sedatives Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |