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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 508 participants.

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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

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00411099

The ClinicalTrials.gov registry entry for NCT00411099 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 508 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

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

NCT00411099 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.