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NCT00467402 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
NCT00467402: Completed Phase 3 study, sponsored by Novartis.
NCT00467402 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 644 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00467402, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
Study Summary
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
Interventions
- DRUG placebo
- DRUG agomelatine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00467402 record still lists
NCT00467402 is an interventional study that assigns participants to a tested intervention. The registered 644 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 (17% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00467402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00467402 about?
NCT00467402 is a clinical study titled "Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder". This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable re...
What is the current status of trial NCT00467402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2007-04.
What interventions are being tested in trial NCT00467402?
The interventions under investigation include: placebo (DRUG), agomelatine (DRUG).
Who is sponsoring clinical trial NCT00467402?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00467402's enrollment target sits among peer trials
644 572nd of 2000 higher than 1,428 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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