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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 644 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00467402
The ClinicalTrials.gov registry entry for NCT00467402 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 644 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.
NCT00467402 reports 0 study locations.
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.
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