A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
NCT ID: NCT05593029
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
929 participants
INTERVENTIONAL
2022-11-09
2025-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SEP-363856 & ADT (Antidepressant Therapy)
SEP-363856
Tablet
Placebo & ADT (Antidepressant Therapy)
Placebo
Placebo
Interventions
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SEP-363856
Tablet
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Scottsdale Clinical Research
Scottsdale, Arizona, United States
DelSol Research
Tucson, Arizona, United States
Pillar Clinical Research
Bentonville, Arkansas, United States
ProScience Research Group
Culver City, California, United States
Wr-Pri, Llc
Encino, California, United States
Collaborative NeuroScience Research , LLC
Garden Grove, California, United States
Alliance Research
Long Beach, California, United States
ATP Clinical Research, Inc.
Orange, California, United States
Anderson Clinical Research
Redlands, California, United States
California Mental Behavioral Health
Santee, California, United States
Schuster Medical Research Institute SMRI
Sherman Oaks, California, United States
Viking Clinical Research
Temecula, California, United States
Collaborative Neuroscience Research LLC
Torrance, California, United States
Sunwise Clinical Research with is in Lafayette, CA
Walnut Creek, California, United States
Institute of Living Hartford Hospital
Hartford, Connecticut, United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Central Miami Medical Institute
Miami, Florida, United States
Clinical Neuroscience Solutions Inc. dba CNS Healthcare
Orlando, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
K2 Medical Research
Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Advanced Discovery Research LLC
Atlanta, Georgia, United States
Renew Health Clinical Research
Snellville, Georgia, United States
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Chicago, Illinois, United States
AMR Convention Research
Warrenville, Illinois, United States
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Shreveport, Louisiana, United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, United States
Copley Clinical
Boston, Massachusetts, United States
Boston Clinical Trials
Roslindale, Massachusetts, United States
Adams Clinical
Watertown, Massachusetts, United States
Vitalix Clinical
Worcester, Massachusetts, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Integrative Clinical Trials
Brooklyn, New York, United States
Basil Clinical
Inwood, New York, United States
Berman Clinical
New York, New York, United States
Manhattan Behavioral Medicine PLLC
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Patient Priority Clinical Studies LLC
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Suburban Research Associates
West Chester, Pennsylvania, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, United States
Community Clinical Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
DM Clinical Research - Belliare
Houston, Texas, United States
Psychiatric And Behavioral Solutions, LLC
Millcreek, Utah, United States
Core Clinical Research
Everett, Washington, United States
Diagnostic Consultive Center Higya AD
Pazardzhik, , Bulgaria
Ambulatory for Group Practice for Specialized Psychiatrics Help PHILIPOPOLIS OOD
Plovdiv, , Bulgaria
Medical Center Sveti Naum
Sofia, , Bulgaria
DCC-Mladost M OOD
Varna, , Bulgaria
Mental Health Center Vratsa
Vratsa, , Bulgaria
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada
Institute of Mental Health Research IMHR
Ottawa, Ontario, Canada
Centre for Addiction and Mental Health (CAMH & University of Toronto)
Toronto, Ontario, Canada
BRAIN-SOULTHERAPY s.r.o.
Kladno, Central Bohemia, Czechia
A-Shine s.r.o.
Ptzen, Plzeň Region, Czechia
National Institute of Mental Health
Klecany, , Czechia
Clintrial s.r.o.
Prague, , Czechia
Velocity Clinical Research Wiesbaden
Wiesbaden, Hesse, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, MA, Germany
Private Practice Kusserow
Stralsund, Mecklenburg-Vorpommern, Germany
Somni Bene Institut for Medical Research
Schwerin, Mecklenburg, Germany
Arztepartnerschaft Dr. med. J. Springhub/ W. Schwarz-Studienzentrum Nord-West
Westerstede, , Germany
ClinExpert Kft.
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Praktyka Lekarska Malgorzata Wojtanowska-Bogacka
Poznan, Greater Poland Voivodeship, Poland
Osrodek Badan Klinicznych CLINSANTE
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MlynowaMed - Bialystok
Bialystok, OH, Poland
Centrum Medyczne Luxmed Sp.z. o.o.
Lublin, , Poland
Indywidualna SpecjalistycznaPraktyka Lekarska AgnieszkaRemlinger-Molenda
Szkolkarska 32, , Poland
Countries
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Other Identifiers
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382-201-00001
Identifier Type: -
Identifier Source: org_study_id
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