drugset / Trial / NCT00463242
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)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Agomelatine | Small molecule | 25 mg | Oral |
| Subject | Agomelatine | Small molecule | 50 mg | Oral |
| Comparator | Paroxetine | Small molecule | — | — |