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NCT01110889 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 582
- Enrollment target
NCT01110889: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01110889 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 582 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110889, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 582 participants
- Enrollment target
Study Summary
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
Interventions
- DRUG Placebo
- DRUG Agomelatine (AGO178C)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2010-05 |
| Phase | Phase 3 |
What the finished NCT01110889 record still lists
NCT01110889 is an interventional study that assigns participants to a tested intervention. The registered 582 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 (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01110889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01110889 about?
NCT01110889 is a clinical study titled "Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder". The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
What is the current status of trial NCT01110889?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2010-05.
What interventions are being tested in trial NCT01110889?
The interventions under investigation include: Placebo (DRUG), Agomelatine (AGO178C) (DRUG).
Who is sponsoring clinical trial NCT01110889?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01110889's enrollment target sits among peer trials
582 653rd of 2000 higher than 1,345 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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