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NCT03569475 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 501
- Enrollment target
- 20
- Study locations
NCT03569475: Completed Phase 3 study of Major Depressive Disorder, sponsored by Allergan.
NCT03569475 is a Phase 3 study of Major Depressive Disorder that has completed, run by Allergan. The registered enrollment target is 501 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03569475, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 501 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6-17 years. It contains 17 ordinally-scaled items that evaluate the 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 i
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 |
What the finished NCT03569475 record still lists
NCT03569475 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (34% higher).
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.
NCT03569475 names 20 study sites across 5 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT03569475?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT03569475?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03569475's enrollment target sits among peer trials
501 31st of 282 higher than 252 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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.
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