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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 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 552 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431806
The ClinicalTrials.gov registry entry for NCT02431806 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 552 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02431806 reports 0 study locations.
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.
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