A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.60 sites in 1 country337 target enrollmentSeptember 12, 2022

ConditionsMajor Depressive Disorder

InterventionsEscitalopram Centanafadine Placebo

Overview

Phase: Phase 2
Intervention: Escitalopram
Conditions: Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 337
Locations: 60
Primary Endpoint: Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 12, 2022

End Date

May 16, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility 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.