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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Centanafadine; Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT05536414
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-09-12
• Status Verified: 2025-05
• Primary Completion: 2025-05-16
• Study Completion: 2025-05-16
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Centanafadine + Placebo	Placebo	-
Escitalopram + Placebo	Placebo	-
Placebo + Placebo	Placebo	-
Centanafadine + Escitalopram	Escitalopram	-
Escitalopram + Placebo	Escitalopram	-
Centanafadine + Placebo	Centanafadine	-
Centanafadine + Escitalopram	Centanafadine	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.	Baseline, Week 6

Trial Locations

Locations (60)

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

Scroll for more (50 remaining)