Condition: Major Depressive Disorder · Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
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.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
| 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 | — |
+ 50 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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