A Phase 3 interventional study of Agomelatine (AGO178C) and Placebo in Major Depressive Disorder, sponsored by Novartis Pharmaceuticals. Completed at 45 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 589 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: Agomelatine (AGO178C)
Drug: Agomelatine (AGO178C)
Drug: Placebo
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Time frame: Baseline and 8 weeks
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
Time frame: 8 weeks
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
Time frame: 8 weeks
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
Time frame: 8 weeks
Proportion of patients who achieve remission
Time frame: 8 weeks
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.
Time frame: 8 weeks
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals