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NCT01034462 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT01034462: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01034462 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034462, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder
Primary Outcome
MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT01034462 record still lists
NCT01034462 is an interventional study that assigns participants to a tested intervention. The registered 442 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01034462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01034462 about?
NCT01034462 is a clinical study titled "Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder
What is the current status of trial NCT01034462?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2009-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01034462?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT01034462?
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 NCT01034462's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 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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