Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
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|ClinicalTrials.gov Identifier: NCT01156415|
Recruitment Status : Terminated
First Posted : July 2, 2010
Last Update Posted : March 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: AGO178||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||837 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2010|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
|Experimental: Agomelatine (AGO178) 0.5 mg||Drug: AGO178|
|Experimental: Agomelatine (AGO178) 1 mg||Drug: AGO178|
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156415
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|