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

Study Identifier:
405-201-00062
ClinicalTrials.gov Identifier:
NCT05536414
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • Depression
Study Drug
  • Drug: Centanafadine
  • Drug: Escitalopram
  • Drug: Placebo
Date
Sep 2022 - May 2025
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
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.
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.

Protocol Summary

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 Locations

Location
Status
Location
Yuma CNS Research
Yuma, Arizona, United States, 85365-4905
Status
N/A
Location
SanRo Clinical Research Group LLC
Bryant, Arkansas, United States, 72022-9252
Status
N/A
Location
Behavioral Research Specialists-California-Irvine
Glendale, California, United States, 91206-4282
Status
N/A
Location
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, United States, 94549
Status
N/A
Location
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, United States, 93534-5504
Status
N/A
Location
Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, United States, 91945-2956
Status
N/A
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.
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.

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