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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 501 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00463242
The ClinicalTrials.gov registry entry for NCT00463242 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 501 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 3 interventions - of which placebo is the first listed.
NCT00463242 reports 0 study locations.
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.
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