A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Official Title
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An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Agomelatine
* Drug: paroxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults, 18 through 70 years of age, inclusive Diagnosis of Major Depressive Disorder according to DSM-IV criteria HAM-D17 total score > or = 22 at Screening and Baseline Exclusion Criteria: History of non-response to paroxetine Patients who have been previously treated with agomelatine 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 Use of any psychoactive medication after the screening visit 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: Agomelatine<br>Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began. | Drug: Agomelatine<br>* Either 25 mg or 50 mg agomelatine orally once daily<br>|
| Active Comparator: 2<br> | Drug: paroxetine<br> <br> * Other names: Paxil;|
| 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 Hamilton Depression Rating Scale |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX). |  | 8 weeks | 
| Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8. |  | 8 weeks | 
| Proportion of patients with MDD who achieve remission, |  | 8 weeks | 
| Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD). |  | 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