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

Study Overview
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Brief Summary
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This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Official Title
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An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2302E)

Conditions
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Major Depressive Disorder (MDD)

Intervention / Treatment
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* Drug: agomelatine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria HAM-D17 total score > or = 22 at Screening and Baseline CGI-Severity score > or = 4 at Screening and Baseline Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase Exclusion Criteria: History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder Any current Axis I disorder other than major depressive disorder 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 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: 1<br> | Drug: agomelatine<br> <br> |
| Experimental: 2<br> | Drug: agomelatine<br> <br> |
| Placebo Comparator: 3<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 Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the 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 | 
| To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17 |  | 8 weeks | 
| To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8 |  | 8 weeks | 
| To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 |  | 8 weeks | 
| To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 |  | 8 weeks | 

 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