NCT05593029CompletedPhase 2
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
Otsuka Pharmaceutical Development & Commercialization, Inc.151 sites in 1 country929 target enrollmentStarted: November 9, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 929
- Locations
- 151
- Primary Endpoint
- Montgomery Åsberg Depression Rating Scale (MADRS)
Study Overview
Brief Summary
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 response to prior ADT therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
SEP-363856 & ADT (Antidepressant Therapy)
Experimental
Intervention: SEP-363856 (Drug)
Placebo & ADT (Antidepressant Therapy)
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame: 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 Outcomes
- Clinical Global Impression - Severity of Illness (CGI-S)(From baseline to week 14)
Investigators
Study Sites (151)
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