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NCT01377194 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
NCT01377194: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01377194 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 568 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377194, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
Primary Outcome
The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity)
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01377194 record still lists
NCT01377194 is an interventional study that assigns participants to a tested intervention. The registered 568 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 (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01377194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377194 about?
NCT01377194 is a clinical study titled "Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
What is the current status of trial NCT01377194?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2011-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01377194?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT01377194?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01377194's enrollment target sits among peer trials
568 666th of 2000 higher than 1,334 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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