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NCT02288325 · ClinicalTrials.gov registry record · Phase 4
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 644
- Enrollment target
NCT02288325: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT02288325 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 644 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02288325, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 644 participants
- Enrollment target
Study Summary
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
Primary Outcome
Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a \>/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening o
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2016-09-16 |
| Phase | Phase 4 |
What the finished NCT02288325 record still lists
NCT02288325 is an interventional study that assigns participants to a tested intervention. The registered 644 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02288325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02288325 about?
NCT02288325 is a clinical study titled "A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder". This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
What is the current status of trial NCT02288325?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 644 participants. The study started on 2014-11-18. Estimated completion is 2016-09-16.
What interventions are being tested in trial NCT02288325?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT02288325?
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 NCT02288325's enrollment target sits among peer trials
644 126th of 2000 higher than 1,875 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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