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

Novartis

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: placebo; Drug: agomelatine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411099

CAGO178A2301

Details and patient eligibility

About

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.

Enrollment: 508 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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508 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: agomelatine

2

Experimental group

Treatment:

Drug: agomelatine

3

Placebo Comparator group

Treatment:

Drug: placebo