Trials / Completed
CompletedNCT00411242
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2302E)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 503 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | agomelatine | |
| DRUG | placebo |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-01-01
- First posted
- 2006-12-13
- Last updated
- 2020-12-23
Locations
51 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00411242. Inclusion in this directory is not an endorsement.