Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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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.

Official Title
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A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: AGO178
* Drug: AGO178


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Key Inclusion Criteria Cohort I: Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients. Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study). Female patients should continue to use effective contraception as defined in double-blind study protocol. Inclusion Criteria: Key Inclusion criteria Cohort II: Male and female adults, 18 through 70 years of age, inclusive. Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria. Current episode ≥4 weeks. CGI-Severity score ≥4 at Screening and Baseline. Exclusion Criteria: Key Exclusion Criteria Cohort I: Concomitant use of fluvoxamine. Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator. Exclusion Criteria: Key Exclusion criteria Cohort II: History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder. Any other current Axis I disorder other than MDD which is the focus of treatment. Substance or alcohol abuse in the last 30 days, dependence in the last 6 months. Prior exposure to agomelatine. Female patients of childbearing potential who are not using effective contraception. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Agomelatine (AGO178) 0.5 mg<br> | Drug: AGO178<br> <br> |
| Experimental: Agomelatine (AGO178) 1 mg<br> | Drug: AGO178<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale |  | 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 |  | 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 |  | 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 |  | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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agomelatine, Major Depressive Disorder, MDD, depression