# 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)

> **NCT00463242** · PHASE3 · COMPLETED · sponsor: **Novartis** · enrollment: 501 (actual)

## Conditions studied

- Major Depressive Disorder

## Interventions

- **DRUG:** Agomelatine
- **DRUG:** paroxetine
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT00463242
- **Lead sponsor:** Novartis
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-03
- **Primary completion:** 2008-06
- **Final completion:** —
- **Target enrollment:** 501 (ACTUAL)
- **Last updated:** 2020-12-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00463242

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT00463242. Licensed CC0.

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