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.

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

Major Depressive Disorder

Depression

placebo

ulotorant (SEP-363856)

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

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.

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.

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)

For additional information regarding sites, contact 844-687-8522

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.

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.

Placebo

SEP-363856

University of Alabama at Birmingham

Scottsdale Clinical Research

DelSol Research

Pillar Clinical Research

ProScience Research Group

Wr-Pri, Llc

Collaborative NeuroScience Research , LLC

Alliance Research

ATP Clinical Research, Inc.

Anderson Clinical Research

California Mental Behavioral Health

Schuster Medical Research Institute SMRI

Viking Clinical Research

Collaborative Neuroscience Research LLC

Sunwise Clinical Research with is in Lafayette, CA

Institute of Living Hartford Hospital

Clinical Neuroscience Solutions Inc.

K2 Medical Research

Central Miami Medical Institute

Clinical Neuroscience Solutions Inc. dba CNS Healthcare

Combined Research Orlando Phase I-IV

Interventional Psychiatry of Tampa Bay

Advanced Discovery Research LLC

Renew Health Clinical Research

MetroMed Clinical Trials

AMR Convention Research

Benchmark Research

Cenexel CBH (CBH Health)

Copley Clinical

Boston Clinical Trials

Adams Clinical

Vitalix Clinical

Neurobehavioral Medicine Group

Precise Research Centers

Center for Emotional Fitness

Integrative Clinical Trials

Basil Clinical

Berman Clinical

Manhattan Behavioral Medicine PLLC

The Medical Research Network, LLC

Patient Priority Clinical Studies LLC

The Ohio State University

Sooner Clinical Research

Suburban Research Associates

Donald J. Garcia, Jr., MD, PA

Community Clinical Research, Inc.

FutureSearch Trials of Dallas

North Texas Clinical Trials

DM Clinical Research - Belliare

Psychiatric And Behavioral Solutions, LLC

Core Clinical Research

Diagnostic Consultive Center Higya AD

Ambulatory for Group Practice for Specialized Psychiatrics Help PHILIPOPOLIS OOD

Medical Center Sveti Naum

DCC-Mladost M OOD

Mental Health Center Vratsa

Chatham-Kent Clinical Trials Research Centre

Institute of Mental Health Research IMHR

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

BRAIN-SOULTHERAPY s.r.o.

A-Shine s.r.o.

National Institute of Mental Health

Clintrial s.r.o.

Velocity Clinical Research Wiesbaden

Pharmakologisches Studienzentrum Chemnitz GmbH

Private Practice Kusserow

Somni Bene Institut for Medical Research

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

ClinExpert Kft.

Semmelweis University

Praktyka Lekarska Malgorzata Wojtanowska-Bogacka

Osrodek Badan Klinicznych CLINSANTE

MlynowaMed - Bialystok

Centrum Medyczne Luxmed Sp.z. o.o.

Indywidualna SpecjalistycznaPraktyka Lekarska AgnieszkaRemlinger-Molenda

Trial at a glance

Trial results

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

CT.gov ID:

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