Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Agomelatine (AGO178C)
* Drug: Agomelatine (AGO178C)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with 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: 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. Concomitant psychotropic medication, including herbal preparations and melatonin. Psychotherapy of any type. 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: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGO178C 0.5 mg /day<br> | Drug: Agomelatine (AGO178C)<br> <br> |
| Experimental: AGO178C 1 mg / day<br> | Drug: Agomelatine (AGO178C)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale |  | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain quality of sleep at Week 8 |  | 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 |  | 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 |  | 8 weeks | 
| Proportion of patients who achieve remission |  | 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. |  | 8 weeks | 

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