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NCT00463242 · ClinicalTrials.gov registry record · Phase 3
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
NCT00463242: Completed Phase 3 study, sponsored by Novartis.
NCT00463242 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 501 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00463242, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
Interventions
- DRUG placebo
- DRUG paroxetine
- DRUG Agomelatine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2007-03 |
| Phase | Phase 3 |
What the finished NCT00463242 record still lists
NCT00463242 is an interventional study that assigns participants to a tested intervention. The registered 501 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 (35% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00463242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00463242 about?
NCT00463242 is a clinical study titled "A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)". This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there...
What is the current status of trial NCT00463242?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2007-03.
What interventions are being tested in trial NCT00463242?
The interventions under investigation include: placebo (DRUG), paroxetine (DRUG), Agomelatine (DRUG).
Who is sponsoring clinical trial NCT00463242?
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 NCT00463242's enrollment target sits among peer trials
501 743rd of 2000 higher than 1,257 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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