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NCT03586427 · ClinicalTrials.gov registry record · Phase 2
AGN-241751 in the Treatment of Major Depressive Disorder
A Phase 2 study of Depressive Disorder, Major, sponsored by Syndeio Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT03586427: Completed Phase 2 study of Depressive Disorder, Major, sponsored by Syndeio Biosciences.
NCT03586427 is a Phase 2 study of Depressive Disorder, Major that has completed, run by Syndeio Biosciences. The registered enrollment target is 251 participants, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03586427, a Phase 2 study of Depressive Disorder, Major, has completed, sponsored by Syndeio Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of AGN-241751 compared with placebo in participants with Major Depressive Disorder (MDD).
Primary Outcome
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AGN-241751
Study Locations (20)
California
- Synexus US - Cerritos - Cerritos
- Wake Research - Pharmacology Research Institute - Encino
- Wake Research - Pharmacology Research Institute - Newport Beach
- Pacific Research Partners, LLC - Oakland
- North County Clinical Research, Inc. - Oceanside
- Collaborative Neuroscience Network - Torrance
- Elite Clinical Trials, Inc. - Wildomar
New York
- Neurobehavioral Research, Inc - Cedarhurst
- Synexus US - Queens - Jamaica
- Eastside Comprehensive Medical Center - New York
- Finger Lakes Clinical Research - Rochester
Georgia
- Synexus US - Atlanta - Atlanta
- Atlanta Center for Medical Research - Atlanta
New Jersey
- Hassman Research Institute - Berlin
- Center for Emotional Fitness - Cherry Hill
Arkansas
- Health Initiatives Research PLLC - Fayetteville
Illinois
- Pillar Clinical Research - Lincolnwood
Massachusetts
- Boston Clinical Trials - Boston
Ohio
- Neuro-Behavioral Clinical Research, Inc - North Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2018-06-13 |
| Est. Completion | 2019-08-21 |
| Phase | Phase 2 |
What the finished NCT03586427 record still lists
NCT03586427 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target.
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03586427 names 20 study sites across 9 states, led by California, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT03586427 about?
NCT03586427 is a clinical study titled "AGN-241751 in the Treatment of Major Depressive Disorder". The purpose of this study is to evaluate the efficacy at 1 day post initial oral dose of AGN-241751 compared with placebo in participants with Major Depressive Disorder (MDD).
What is the current status of trial NCT03586427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2018-06-13. Estimated completion is 2019-08-21.
What conditions does trial NCT03586427 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT03586427?
The interventions under investigation include: Placebo (DRUG), AGN-241751 (DRUG).
Who is sponsoring clinical trial NCT03586427?
This trial is sponsored by Syndeio Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03586427 being conducted?
This trial has 20 study locations across Arkansas, California, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03586427's enrollment target sits among peer trials
251 18th of 52 higher than 35 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major 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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