# Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder

> **NCT00467402** · PHASE3 · COMPLETED · sponsor: **Novartis** · enrollment: 644 (actual)

## Conditions studied

- Major Depressive Disorder

## Interventions

- **DRUG:** agomelatine
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT00467402
- **Lead sponsor:** Novartis
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-04
- **Primary completion:** 2009-09
- **Final completion:** —
- **Target enrollment:** 644 (ACTUAL)
- **Last updated:** 2020-12-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00467402

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00467402, "Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00467402. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
