A Phase 3 interventional study of Agomelatine and paroxetine in Major Depressive Disorder, sponsored by Novartis. Completed at 47 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 501 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
Drug: Agomelatine
Drug: paroxetine
Drug: placebo
Either 25 mg or 50 mg agomelatine orally once daily
Also known as: Paxil
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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