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

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

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