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Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
NCT03569475 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluoxetine
- DRUG Levomilnacipran ER
Study Locations (20)
California
- Care Access Research, Beverly Hills — Beverly Hills
- Kindred Medical Institute for Clinical Trials, LLC — Corona
- Behavioral Research Specialists, LLC — Glendale
- Sun Valley Research Center — Imperial
- Alliance Research — Long Beach
- Excell Research, Inc. — Oceanside
- NRC Research Institute — Orange
- Elite Clinical Trials, Inc. — Wildomar
Florida
- Advanced Research Institute of Miami — Homestead
- Clinical Neuroscience Solutions, Inc — Jacksonville
- Zynak Clinical — Lauderdale Lakes
- Columbus Clinical Services, LLC — Miami
- Clinical Neuroscience Solutions, Inc. — Orlando
Georgia
- Atlanta Center for Medical Research — Atlanta
- Atlanta Behavioral Research, LLC — Atlanta
- iResearch Atlanta — Decatur
- Attalla Consultants, LLC — Smyrna
- Clinical Research Institute — Stockbridge
Arkansas
- Woodland International Research Group — Little Rock
District of Columbia
- Children's National Health System — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2018-07-06 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03569475
The ClinicalTrials.gov registry entry for NCT03569475 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 501 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03569475 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03569475 about?
NCT03569475 is a clinical study titled "Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder". The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
What is the current status of trial NCT03569475?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 501 participants. The study started on 2018-07-06. Estimated completion is 2021-03-01.
What conditions does trial NCT03569475 study?
This clinical trial studies the following conditions: Major Depressive Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03569475?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG), Levomilnacipran ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03569475?
This trial is sponsored by Allergan, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03569475 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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