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NCT00411099 · ClinicalTrials.gov registry record · Phase 3

Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
508
Enrollment target

NCT00411099: Completed Phase 3 study, sponsored by Novartis.

NCT00411099 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 508 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00411099, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
508 participants
Enrollment target

Study Summary

This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

Interventions

  • DRUG placebo
  • DRUG agomelatine

Trial Details

FieldValue
Enrollment Target 508 participants
Start Date 2006-12
Phase Phase 3
Novartis

265 total trials

What the finished NCT00411099 record still lists

NCT00411099 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00411099 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00411099 about?

NCT00411099 is a clinical study titled "Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder". This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.

What is the current status of trial NCT00411099?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2006-12.

What interventions are being tested in trial NCT00411099?

The interventions under investigation include: placebo (DRUG), agomelatine (DRUG).

Who is sponsoring clinical trial NCT00411099?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00411099's enrollment target sits among peer trials

508 737th of 2000 higher than 1,262 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00411099, the US trial registry maintained by the National Library of Medicine. NCT00411099 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.