NCT02431806 is a Phase 3 clinical trial of Levomilnacipran in Major Depressive Disorder, sponsored by Forest Laboratories.

Who is sponsoring NCT02431806?

NCT02431806 is sponsored by Forest Laboratories.

What drugs are being tested in NCT02431806?

Interventions in NCT02431806: Placebo, Levomilnacipran, Fluoxetine.

What condition does NCT02431806 study?

NCT02431806 studies Major Depressive Disorder.

Is NCT02431806 still recruiting?

NCT02431806 is currently completed. Last updated 7 September 2020.

Are results published for NCT02431806?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-09-07 · How we verify

NCT02431806

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

Completed Phase 3 Results posted Last updated 7 September 2020

What this trial tests

Phase 3 trial testing Placebo in Major Depressive Disorder in 552 participants. Completed in 19 August 2019.

Timeline

23 June 2015

Primary endpoint
19 August 2019

19 August 2019

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	552
Start date	23 June 2015
Primary completion	19 August 2019
Estimated completion	19 August 2019
Sites	49 locations across United States, Puerto Rico

Drugs / interventions tested

Placebo
Levomilnacipran (LEVOMILNACIPRAN) — full drug profile →
Fluoxetine (fluoxetine) — full drug profile →

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Forest Laboratories — full company profile →

Who can join

Adults 12 to 17, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

New generation antidepressants for depression in children and adolescents: a network meta-analysis.
Hetrick SE, McKenzie JE, Bailey AP, Sharma V, et al · · 2021 · cited 89× · PMID 34029378 · DOI 10.1002/14651858.cd013674.pub2
Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies.
Radecki DT, Robieson WZ, Gopalkrishnan M, Greenberg E, et al · · 2024 · cited 5× · PMID 38700708 · DOI 10.1089/cap.2023.0080
New Somatic Treatments for Child and Adolescent Depression.
Cullen KR, Padilla LE, Papke VN, Klimes-Dougan B. · · 2019 · cited 4× · PMID 33312841 · DOI 10.1007/s40501-019-00194-8
Too Many Avoidable Suicides Occur Worldwide in Young Patients.
Rose K, Neubauer D, Grant-Kels JM. · · 2019 · cited 2× · PMID 31545703 · DOI 10.5041/rmmj.10374

Verify or expand the search:

Other trials of Levomilnacipran

Trials testing the same drug.

NCT03249311 — Levomilnacipran in Healthy Males · Phase 4 · unknown
NCT02720198 — Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD · Phase 3 · completed

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Forest Laboratories trials

Trials by the same sponsor.

NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage · completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer · Phase 2 · terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode · Phase 3 · completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres · Phase 3 · completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02431806 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 7 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02431806.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing