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New depression drug shows promise in large trial

NCT ID NCT05593029

Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding an experimental drug called SEP-363856 to standard antidepressants can better reduce depression symptoms in adults who didn't respond well to prior treatments. About 929 participants took either the drug or a placebo alongside their usual medication. The goal was to see if the drug could improve scores on depression rating scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SEP-363856 (an experimental drug)
What this could lead to
If it works, this could offer a new option for people with depression who haven't gotten enough relief from standard antidepressants alone.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

929 people

The number who actually took part.

Started

Nov 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • A-Shine s.r.o.

    Ptzen, Plzeň Region, 30100, Czechia

  • AMR Convention Research

    Warrenville, Illinois, 60555, United States

  • ATP Clinical Research, Inc.

    Orange, California, 92868, United States

  • Adams Clinical

    Watertown, Massachusetts, 02471, United States

  • Advanced Discovery Research LLC

    Atlanta, Georgia, 30318, United States

  • Alliance Research

    Long Beach, California, 90807, United States

  • Ambulatory for Group Practice for Specialized Psychiatrics Help PHILIPOPOLIS OOD

    Plovdiv, 4002, Bulgaria

  • Anderson Clinical Research

    Redlands, California, 92374, United States

  • Arztepartnerschaft Dr. med. J. Springhub/ W. Schwarz-Studienzentrum Nord-West

    Westerstede, 26655, Germany

  • BRAIN-SOULTHERAPY s.r.o.

    Kladno, Central Bohemia, 272 01, Czechia

  • Basil Clinical

    Inwood, New York, 11096, United States

  • Benchmark Research

    Shreveport, Louisiana, 71101, United States

  • Berman Clinical

    New York, New York, 10029, United States

  • Boston Clinical Trials

    Roslindale, Massachusetts, 02131, United States

  • California Mental Behavioral Health

    Santee, California, 92071, United States

  • Cenexel CBH (CBH Health)

    Gaithersburg, Maryland, 20877, United States

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Central Miami Medical Institute

    Miami, Florida, 33125, United States

  • Centre for Addiction and Mental Health (CAMH & University of Toronto)

    Toronto, Ontario, M6J 1H4, Canada

  • Centrum Medyczne Luxmed Sp.z. o.o.

    Lublin, 20-109, Poland

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario, N7L 1C1, Canada

  • ClinExpert Kft.

    Budapest, 1033, Hungary

  • Clinical Neuroscience Solutions Inc.

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions Inc. dba CNS Healthcare

    Orlando, Florida, 32801, United States

  • Clintrial s.r.o.

    Prague, 10000, Czechia

  • Collaborative NeuroScience Research , LLC

    Garden Grove, California, 92845, United States

  • Collaborative Neuroscience Research LLC

    Torrance, California, 90504, United States

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807, United States

  • Community Clinical Research, Inc.

    Austin, Texas, 78754, United States

  • Copley Clinical

    Boston, Massachusetts, 02116, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • DCC-Mladost M OOD

    Varna, 9020, Bulgaria

  • DM Clinical Research - Belliare

    Houston, Texas, 77081, United States

  • DelSol Research

    Tucson, Arizona, 85715, United States

  • Diagnostic Consultive Center Higya AD

    Pazardzhik, 4400, Bulgaria

  • Donald J. Garcia, Jr., MD, PA

    Austin, Texas, 78737, United States

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75251, United States

  • Indywidualna SpecjalistycznaPraktyka Lekarska AgnieszkaRemlinger-Molenda

    Szkolkarska 32, 62-002, Poland

  • Institute of Living Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Institute of Mental Health Research IMHR

    Ottawa, Ontario, K1Z 7K4, Canada

  • Integrative Clinical Trials

    Brooklyn, New York, 11229, United States

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629, United States

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • K2 Medical Research

    Tampa, Florida, 33607, United States

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036, United States

  • Medical Center Sveti Naum

    Sofia, 1113, Bulgaria

  • Mental Health Center Vratsa

    Vratsa, 3000, Bulgaria

  • MetroMed Clinical Trials

    Chicago, Illinois, 60614, United States

  • MlynowaMed - Bialystok

    Bialystok, OH, 15-404, Poland

  • National Institute of Mental Health

    Klecany, 25067, Czechia

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104, United States

  • Osrodek Badan Klinicznych CLINSANTE

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-794, Poland

  • Patient Priority Clinical Studies LLC

    Cincinnati, Ohio, 45215, United States

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Chemnitz, MA, 09111, Germany

  • Pillar Clinical Research

    Bentonville, Arkansas, 72712, United States

  • Praktyka Lekarska Malgorzata Wojtanowska-Bogacka

    Poznan, Greater Poland Voivodeship, 60-192, Poland

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

  • Private Practice Kusserow

    Stralsund, Mecklenburg-Vorpommern, 18439, Germany

  • ProScience Research Group

    Culver City, California, 90230, United States

  • Psychiatric And Behavioral Solutions, LLC

    Millcreek, Utah, 84124, United States

  • Renew Health Clinical Research

    Snellville, Georgia, 30078, United States

  • Schuster Medical Research Institute SMRI

    Sherman Oaks, California, 91403, United States

  • Scottsdale Clinical Research

    Scottsdale, Arizona, 85260, United States

  • Semmelweis University

    Budapest, M6J 1H4, Hungary

  • Somni Bene Institut for Medical Research

    Schwerin, Mecklenburg, 19053, Germany

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73116, United States

  • Suburban Research Associates

    West Chester, Pennsylvania, 19380, United States

  • Sunwise Clinical Research with is in Lafayette, CA

    Walnut Creek, California, 94596, United States

  • The Medical Research Network, LLC

    New York, New York, 10128, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • Velocity Clinical Research Wiesbaden

    Wiesbaden, Hesse, 65189, Germany

  • Viking Clinical Research

    Temecula, California, 92591, United States

  • Vitalix Clinical

    Worcester, Massachusetts, 01608, United States

  • Wr-Pri, Llc

    Encino, California, 91316, United States

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Other studies related to the condition(s) this trial covers.