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NCT01254305 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 262
- Enrollment target
NCT01254305: Completed Phase 2 study, sponsored by Forest Laboratories.
NCT01254305 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 262 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01254305, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
Primary Outcome
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
- DRUG Paroxetine, Sertraline, Citalopram or Fluoxetine.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01254305 record still lists
NCT01254305 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01254305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01254305 about?
NCT01254305 is a clinical study titled "Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder". The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
What is the current status of trial NCT01254305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2011-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01254305?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG), Paroxetine, Sertraline, Citalopram or Fluoxetine. (DRUG).
Who is sponsoring clinical trial NCT01254305?
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 NCT01254305's enrollment target sits among peer trials
262 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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