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)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Paroxetine; S 20098

Criteria

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