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

Phase 3

Completed

Brief Summary: This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.

Recruitment & Eligibility

Inclusion Criteria

Male and female adults, 18 through 70 years of age, inclusive
Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
A history of at least two previous episodes of Major Depression plus the current episode
Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline

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
Use of any psychoactive medication after the screening visit
Patients who have been previously treated with agomelatine
Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
suicide attempt or suicide;	Primary efficacy variable is measured from randomization to relapse
Time to relapse, where relapse is defined by the occurrence of any one of the following:	Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.	Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;	Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;	Primary efficacy variable is measured from randomization to relapse

Secondary Outcome Measures

Name	Time	Method
Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.	Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D.	Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale.	Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients experiencing relapse during the double-blind continuation phase.	Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase