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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
501
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
Time frame: 8 weeks
To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).
Time frame: 8 weeks
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.
Time frame: 8 weeks
Proportion of patients with MDD who achieve remission,
Time frame: 8 weeks
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
Time frame: 8 weeks
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Novartis Investigative Site
Phoenix, Arizona, United States
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National City, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Pico Rivera, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
...and 37 more locations