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)

Novartis

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Agomelatine; Drug: placebo; Drug: paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463242

CAGO178A2303

Details and patient eligibility

About

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.

Enrollment: 501 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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501 participants in 3 patient groups, including a placebo group

Agomelatine

Experimental group

Description:

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.

Treatment:

Drug: Agomelatine

2

Active Comparator group

Treatment:

Drug: paroxetine

3

Placebo Comparator group

Treatment:

Drug: placebo