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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 Oct 27, 2026, 6:05 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05536414
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
337 participants

Conditions and interventions

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 12, 2022 (Actual)
Primary completion
May 16, 2025 (Actual)
Completion
May 16, 2025 (Actual)
Last update posted
May 14, 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 14, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05536414 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →