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Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
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.
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
337
Start Date
2022-09-12
Completion Date
2025-05-16
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
Centanafadine
capsule
Escitalopram
capsule
Placebo
capsule
Locations (62)
Yuma CNS Research
Yuma, Arizona, United States
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
Northwest Clinical Trials
Boise, Idaho, United States
Flourish Research - Andersonville - PPDS
Chicago, Illinois, United States
Revive Research Institute
Elgin, Illinois, United States
American Medical Research Inc
Oak Brook, Illinois, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, United States
MTP Psychiatry, LLC
Baltimore, Maryland, United States
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials - Hunt - PPDS
Brooklyn, New York, United States
SPRI Clinical Trials, LLC - ERG - PPDS
Brooklyn, New York, United States
Fieve Clinical Research
New York, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Charak Clinical Research Center
Garfield Heights, Ohio, United States
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
North Canton, Ohio, United States
Cutting Edge Research
Oklahoma City, Oklahoma, United States
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, United States
Suburban Research Associates - ATLAS - West Chester - PPDS
West Chester, Pennsylvania, United States
LLM Research - South Carolina
Myrtle Beach, South Carolina, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LLC - IVY - PPDS
Dallas, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Houston Mind & Brain
Houston, Texas, United States
Innovative Medical Research of Texas
Houston, Texas, United States
Red Oak Psychiatry Associates P A
Houston, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
AIM Trials
Plano, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Alpine Research Organization, Inc
Clinton, Utah, United States
Cedar Clinical Research - IVY - PPDS
Draper, Utah, United States
The Memory Clinic
Bennington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Core Clinical Research
Everett, Washington, United States