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NCT02431806 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 552
- Enrollment target
NCT02431806: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT02431806 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 552 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431806, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 552 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.
Primary Outcome
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Interventions
- DRUG Placebo
- DRUG Fluoxetine
- DRUG Levomilnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2015-06-23 |
| Est. Completion | 2019-08-19 |
| Phase | Phase 3 |
What the finished NCT02431806 record still lists
NCT02431806 is an interventional study that assigns participants to a tested intervention. The registered 552 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 (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02431806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431806 about?
NCT02431806 is a clinical study titled "Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for ...
What is the current status of trial NCT02431806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 552 participants. The study started on 2015-06-23. Estimated completion is 2019-08-19.
What interventions are being tested in trial NCT02431806?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG), Levomilnacipran (DRUG).
Who is sponsoring clinical trial NCT02431806?
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 NCT02431806's enrollment target sits among peer trials
552 678th of 2000 higher than 1,321 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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