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NCT05536414CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
337 (actual)
First submitted
7 Sept 2022
Start date
12 Sept 2022
Primary completion date
16 May 2025
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Diseases
Depression
NCT number
NCT05536414

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 337
  • From 12 Sept 2022 to the primary completion date, 16 May 2025
  • 62 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Other illness

  • Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
  • Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).

Other

  • Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.

Who the study is looking for

  • Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
  • History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atlanta Center for Medical Research - CenExel ACMR - PPDS
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AtlantaUnited StatesUnknown status
MTP Psychiatry, LLC
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BaltimoreUnited StatesUnknown status
The Memory Clinic
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BenningtonUnited StatesUnknown status
Northwest Clinical Trials
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BoiseUnited StatesUnknown status
SPRI Clinical Trials, LLC - ERG - PPDS
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Integrative Clinical Trials - Hunt - PPDS
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BrooklynUnited StatesUnknown status
Sanro Clinical Research Group, Llc
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BryantUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Flourish Research - Andersonville - PPDS
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ChicagoUnited StatesUnknown status
Patient Priority Clinical Sites LLC
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CincinnatiUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
Alpine Research Organization, Inc
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ClintonUnited StatesUnknown status
CNS Clinical Research Group
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Coral SpringsUnited StatesUnknown status
FutureSearch Trials of Dallas, LLC - IVY - PPDS
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DallasUnited StatesUnknown status
iResearch Atlanta - CenExel - PPDS
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DecaturUnited StatesUnknown status
InSite Clinical Research, LLC
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DeSotoUnited StatesUnknown status
Cedar Clinical Research - IVY - PPDS
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DraperUnited StatesUnknown status
Revive Research Institute
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ElginUnited StatesUnknown status
Core Clinical Research
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EverettUnited StatesUnknown status
Precise Research Centers - ClinEdge - PPDS
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FlowoodUnited StatesUnknown status
Gulfcoast Clinical Research Center
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Fort MyersUnited StatesUnknown status
Charak Clinical Research Center
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Garfield HeightsUnited StatesUnknown status
Behavioral Research Specialists-California-Irvine
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GlendaleUnited StatesUnknown status
Innovative Medical Research of Texas
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HoustonUnited StatesUnknown status
Houston Mind & Brain
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HoustonUnited StatesUnknown status
Red Oak Psychiatry Associates P A
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HoustonUnited StatesUnknown status
University Hills Clinical Research
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IrvingUnited StatesUnknown status
Clinical NeuroScience Solutions Inc
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JacksonvilleUnited StatesUnknown status
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
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LafayetteUnited StatesUnknown status
OM Research LLC - Lancaster - ClinEdge - PPDS
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LancasterUnited StatesUnknown status
Synergy Research Centers - SRC - ERG - PPDS
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Lemon GroveUnited StatesUnknown status
Psych Atlanta
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MariettaUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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MemphisUnited StatesUnknown status
South Florida Research Phase I - IV
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Miami SpringsUnited StatesUnknown status
LLM Research - South Carolina
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Myrtle BeachUnited StatesUnknown status
Fieve Clinical Research
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New YorkUnited StatesUnknown status
Manhattan Behavioral Medicine
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New YorkUnited StatesUnknown status
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
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North CantonUnited StatesUnknown status
Behavioral Clinical Research, Inc
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North MiamiUnited StatesUnknown status
American Medical Research Inc
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Oak BrookUnited StatesUnknown status
Psychiatric Care and Research Center
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O'FallonUnited StatesUnknown status
Cutting Edge Research
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Oklahoma CityUnited StatesUnknown status
NRC Research Institute - Orange - PPDS
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OrangeUnited StatesUnknown status
ATP Clinical Research
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OrangeUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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OrlandoUnited StatesUnknown status
Accelerated Clinical Trials, LLC
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Peachtree CornersUnited StatesUnknown status
AIM Trials
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PlanoUnited StatesUnknown status
Summit Research Network, Inc. - Portland - Headlands - PPDS
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PortlandUnited StatesUnknown status
Prospective Research Innovations
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Rancho CucamongaUnited StatesUnknown status
Anderson Clinical Research - ClinEdge - PPDS
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RedlandsUnited StatesUnknown status
Finger Lakes Clinical Research
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RochesterUnited StatesUnknown status
Lumos Clinical Research
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San JoseUnited StatesUnknown status
Syrentis Clinical Research
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Santa AnaUnited StatesUnknown status
Schuster Medical Research Institute
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Sherman OaksUnited StatesUnknown status
Louisiana Clinical Research, LLC
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ShreveportUnited StatesUnknown status
Richmond Behavioral Associates
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Staten IslandUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
Viking Clinical Research Ltd
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TemeculaUnited StatesUnknown status
Bio Behavioral Health
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Toms RiverUnited StatesUnknown status
Suburban Research Associates - ATLAS - West Chester - PPDS
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West ChesterUnited StatesUnknown status
Grayline Clinical Drug Trials
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Wichita FallsUnited StatesUnknown status
Yuma CNS Research
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YumaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.