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NCT01156415 · ClinicalTrials.gov registry record · Phase 3
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 837
- Enrollment target
NCT01156415: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01156415 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 837 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156415, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 837 participants
- Enrollment target
Study Summary
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study. Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
Interventions
- DRUG AGO178
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
Why NCT01156415 stopped before completion
NCT01156415 is an interventional study that assigns participants to a tested intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which AGO178 is the first listed.
NCT01156415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01156415 about?
NCT01156415 is a clinical study titled "Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)". The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase. Cohort I is restricted to include patients who have completed a previous Novartis...
What is the current status of trial NCT01156415?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 837 participants. The study started on 2010-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01156415?
The interventions under investigation include: AGO178 (DRUG).
Who is sponsoring clinical trial NCT01156415?
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 NCT01156415's enrollment target sits among peer trials
837 395th of 2000 higher than 1,605 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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