Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.
Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.
Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)|
- Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ] [ Designated as safety issue: No ]
- Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale [ Time Frame: Week 6, 8, 12, 28, 36 and 52 ] [ Designated as safety issue: No ]
- Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Agomelatine (AGO178) 0.5 mg||Drug: AGO178|
|Experimental: Agomelatine (AGO178) 1 mg||Drug: AGO178|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|