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Completed Phase 2 Interventional

Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

ClinicalTrials.gov ID: NCT05536414

Public ClinicalTrials.gov record NCT05536414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 19, 2026, 10:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT05536414
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
337 participants

Conditions and interventions

Interventions

  • Centanafadine Drug
  • Escitalopram Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 11, 2022
Primary completion
May 15, 2025
Completion
May 15, 2025
Last update posted
May 13, 2026

2022 – 2025

United States locations

U.S. sites
62
U.S. states
24
U.S. cities
56
Facility City State ZIP Site status
Yuma CNS Research Yuma Arizona 85365-4905
SanRo Clinical Research Group LLC Bryant Arkansas 72022-9252
Behavioral Research Specialists-California-Irvine Glendale California 91206-4282
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS Lafayette California 94549
OM Research LLC - Lancaster - ClinEdge - PPDS Lancaster California 93534-5504
Synergy Research Centers - SRC - ERG - PPDS Lemon Grove California 91945-2956
ATP Clinical Research Orange California 92866
NRC Research Institute - Orange - PPDS Orange California 92868-2847
Prospective Research Innovations Rancho Cucamonga California 91730-4850
Anderson Clinical Research - ClinEdge - PPDS Redlands California 92374-4555
Lumos Clinical Research San Jose California 95124-4108
Syrentis Clinical Research Santa Ana California 92705-8675
Schuster Medical Research Institute Sherman Oaks California 91403-1747
Viking Clinical Research Ltd Temecula California 92591-5285
CNS Clinical Research Group Coral Springs Florida 33067-4644
Gulfcoast Clinical Research Center Fort Myers Florida 33912-4367
Clinical Neuroscience Solutions Inc Jacksonville Florida 32256-6040
South Florida Research Phase I - IV Miami Springs Florida 33166-7225
Behavioral Clinical Research, Inc North Miami Florida 33161-5832
Clinical Neuroscience Solutions Inc Orlando Florida 32801-2987
University of South Florida Tampa Florida 33613-4706
Atlanta Center for Medical Research - CenExel ACMR - PPDS Atlanta Georgia 30331
iResearch Atlanta - CenExel - PPDS Decatur Georgia 30030-3438
Psych Atlanta Marietta Georgia 30060-2585
Accelerated Clinical Trials,LLC Peachtree Corners Georgia 30071-2655
Northwest Clinical Trials Boise Idaho 83704-8638
Flourish Research - Andersonville - PPDS Chicago Illinois 60640-2831
Revive Research Institute Elgin Illinois 60123-9215
American Medical Research Inc Oak Brook Illinois 60523-1818
Louisiana Clinical Research, LLC Shreveport Louisiana 71101-4603
MTP Psychiatry, LLC Baltimore Maryland 21229-1506
Precise Research Centers - ClinEdge - PPDS Flowood Mississippi 39232
Psychiatric Care and Research Center O'Fallon Missouri 63368-8223
Bio Behavioral Health Toms River New Jersey 08755-6434
Integrative Clinical Trials - Hunt - PPDS Brooklyn New York 11229-3576
SPRI Clinical Trials, LLC - ERG - PPDS Brooklyn New York 11235-5660
Fieve Clinical Research New York New York 10017-1945
Manhattan Behavioral Medicine New York New York 10036-4543
Finger Lakes Clinical Research Rochester New York 14618-1609
Richmond Behavioral Associates Staten Island New York 10314
Patient Priority Clinical Sites LLC Cincinnati Ohio 45215-2123
University of Cincinnati Cincinnati Ohio 45219-2498
Charak Clinical Research Center Garfield Heights Ohio 44125-2946
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS North Canton Ohio 44720-1528
Cutting Edge Research Oklahoma City Oklahoma 73116-1423
Summit Research Network, Inc. - Portland - Headlands - PPDS Portland Oregon 97210-5354
Suburban Research Associates - ATLAS - West Chester - PPDS West Chester Pennsylvania 19380-4370
LLM Research - South Carolina Myrtle Beach South Carolina 29577-5898
Clinical Neuroscience Solutions Inc Memphis Tennessee 38119-4806
FutureSearch Trials of Dallas, LLC - IVY - PPDS Dallas Texas 75251
InSite Clinical Research, LLC DeSoto Texas 75115-2066
Houston Mind & Brain Houston Texas 77055-6349
Innovative Medical Research of Texas Houston Texas 77065-4776
Red Oak Psychiatry Associates P A Houston Texas 77090-2607
University Hills Clinical Research Irving Texas 75062-2762
AIM Trials Plano Texas 75093-8346
Grayline Clinical Drug Trials Wichita Falls Texas 76309-1608
Alpine Research Organization, Inc Clinton Utah 84015-8563
Cedar Clinical Research - IVY - PPDS Draper Utah 84020-9884
The Memory Clinic Bennington Vermont 05201-9810
University of Virginia Charlottesville Virginia 22903-9353
Core Clinical Research Everett Washington 98201-4077

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05536414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05536414 live on ClinicalTrials.gov.

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