Clinical trial
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and…
NCT00463242 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00463242 |
|---|---|
| Title | 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) |
| Official title | An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Major Depressive Disorder |
| Intervention type | Drug |
| Interventions | Agomelatine, paroxetine, placebo |
| Enrollment | 501 |
| Start date | Mar 1, 2007 |
| Primary completion | Jun 1, 2008 |
| First posted | Apr 20, 2007 |
| Last update posted | Dec 23, 2020 |
| Countries | Puerto Rico, United States |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: