Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD). The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.
Key facts
- Study ID
- NCT05536414
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 337
- Starts
- 2022-09-12
- Expected to finish
- 2025-05-16
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- SanRo Clinical Research Group LLC — Bryant, Arkansas, United States
- Behavioral Research Specialists-California-Irvine — Glendale, California, United States
- Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS — Lafayette, California, United States
- OM Research LLC - Lancaster - ClinEdge - PPDS — Lancaster, California, United States
- Synergy Research Centers - SRC - ERG - PPDS — Lemon Grove, California, United States
- ATP Clinical Research — Orange, California, United States
- NRC Research Institute - Orange - PPDS — Orange, California, United States
- Prospective Research Innovations — Rancho Cucamonga, California, United States
- Anderson Clinical Research - ClinEdge - PPDS — Redlands, California, United States
- Lumos Clinical Research — San Jose, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- Schuster Medical Research Institute — Sherman Oaks, California, United States
- Viking Clinical Research Ltd — Temecula, California, United States
- CNS Clinical Research Group — Coral Springs, Florida, United States
- Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
- Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
- South Florida Research Phase I - IV — Miami Springs, Florida, United States
- Behavioral Clinical Research, Inc — North Miami, Florida, United States
- Clinical Neuroscience Solutions Inc — Orlando, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Atlanta Center for Medical Research - CenExel ACMR - PPDS — Atlanta, Georgia, United States
- iResearch Atlanta - CenExel - PPDS — Decatur, Georgia, United States
- Psych Atlanta — Marietta, Georgia, United States
- Accelerated Clinical Trials,LLC — Peachtree Corners, Georgia, United States
- Yuma CNS Research — Yuma, Arizona, United States
Full record on ClinicalTrials.gov
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