A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

Otsuka

Status and phase

Active, not recruiting

Phase 2

Conditions

Major Depressive Disorder

Treatments

Other: Placebo

Drug: SEP-363856

Study type

Interventional

Funder types

Industry

Identifiers

NCT05593029

382-201-00001

Details and patient eligibility

About

Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS & CGI-S) in MDD patients who had an inadequate respons

Enrollment

900 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
Current major depressive episode must be at least 8 weeks and no longer than 2 years in duration
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, major or mild neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent/ follow study directions/ or otherwise safely participate in the study, borderline or antisocial 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.