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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05593029

Collaborator

Sumitomo Pharma Co., Ltd. (Industry), Sunovion (Industry)

900

Enrollment

Location

Arms

29.7

Anticipated Duration (Months)

30.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder (MDD)

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: SEP-363856 Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

Actual Study Start Date :

Nov 9, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEP-363856 & ADT (Antidepressant Therapy)	Drug: SEP-363856 Tablet
Placebo Comparator: Placebo & ADT (Antidepressant Therapy)	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: SEP-363856 & ADT (Antidepressant Therapy)

Drug: SEP-363856

Tablet

Placebo Comparator: Placebo & ADT (Antidepressant Therapy)

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Montgomery Åsberg Depression Rating Scale (MADRS) [From baseline to week 14]
Change from the baseline to the Montgomery Åsberg Depression Rating Scale (MADRS) total score. The Montgomery Åsberg Depression Rating Scale consists of 10 items, each rated from 0 to 6 (for a total score of 0 to 60). A higher score represents a higher severity of the level of depression.

Secondary Outcome Measures

Clinical Global Impression - Severity of Illness (CGI-S) [From baseline to week 14]
Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S). Clinical Global Impression - Severity of Illness will be measured on a scale from 1-7 where a higher score represents a higher severity of disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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 current diagnosis of a cognitive, psychotic, bipolar, eating, obsessive-compulsive, panic, post-traumatic stress, or personality disorder
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.