Anxiety & Depression Association of America

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

Purpose

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.

Condition

Major Depressive Disorder

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Centanafadine + Placebo		Drug: Centanafadine capsule Drug: Placebo capsule
Experimental Centanafadine + Escitalopram		Drug: Centanafadine capsule Drug: Escitalopram capsule
Active Comparator Escitalopram + Placebo		Drug: Escitalopram capsule Drug: Placebo capsule
Placebo Comparator Placebo + Placebo		Drug: Placebo capsule

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact

Otsuka Call Center
844-687-8522
OtsukaUS@druginfo.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.