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Study identifier: NCT05536414 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedJUNIPER

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

Condition: Major Depressive Disorder  ·  Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

PhasePhase 2
Planned participants337
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where62 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode. * 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). * 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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (62)

Yuma CNS ResearchYuma, Arizona, United States
SanRo Clinical Research Group LLCBryant, Arkansas, United States
Behavioral Research Specialists-California-IrvineGlendale, California, United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDSLafayette, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDSLancaster, California, United States
Synergy Research Centers - SRC - ERG - PPDSLemon Grove, California, United States
ATP Clinical ResearchOrange, California, United States
NRC Research Institute - Orange - PPDSOrange, California, United States
Prospective Research InnovationsRancho Cucamonga, California, United States
Anderson Clinical Research - ClinEdge - PPDSRedlands, California, United States
Lumos Clinical ResearchSan Jose, California, United States
Syrentis Clinical ResearchSanta Ana, California, United States

+ 50 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

YumaBryantGlendaleLafayette

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