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

NCT05536414 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Centanafadine

capsule

DRUG

Escitalopram

capsule

DRUG

Placebo

capsule

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2025-05-16
Completion
2025-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536414 on ClinicalTrials.gov