COMPLETED

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

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Conditions

Major Depressive DisorderMDDSEP-363856Antidepressant TherapyADTDepressionDepressive DisorderMajor Mood DisordersMental Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-11-09
Study Completion:2025-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05593029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Current major depressive episode must be at least 8 weeks and no longer than 2 years in duration
  3. * History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode
  1. * Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
  2. * 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.
  3. * Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
  4. * 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.

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Scottsdale Clinical Research
Scottsdale, Arizona, 85260
United States
DelSol Research
Tucson, Arizona, 85715
United States
Pillar Clinical Research
Bentonville, Arkansas, 72712
United States
ProScience Research Group
Culver City, California, 90230
United States
Wr-Pri, Llc
Encino, California, 91316
United States
Collaborative NeuroScience Research , LLC
Garden Grove, California, 92845
United States
Alliance Research
Long Beach, California, 90807
United States
ATP Clinical Research, Inc.
Orange, California, 92868
United States
Anderson Clinical Research
Redlands, California, 92374
United States
California Mental Behavioral Health
Santee, California, 92071
United States
Schuster Medical Research Institute SMRI
Sherman Oaks, California, 91403
United States
Viking Clinical Research
Temecula, California, 92591
United States
Collaborative Neuroscience Research LLC
Torrance, California, 90504
United States
Sunwise Clinical Research with is in Lafayette, CA
Walnut Creek, California, 94596
United States
Institute of Living Hartford Hospital
Hartford, Connecticut, 06106
United States
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, 32256
United States
K2 Medical Research
Maitland, Florida, 32751
United States
Central Miami Medical Institute
Miami, Florida, 33125
United States
Clinical Neuroscience Solutions Inc. dba CNS Healthcare
Orlando, Florida, 32801
United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
United States
K2 Medical Research
Tampa, Florida, 33607
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
United States
Advanced Discovery Research LLC
Atlanta, Georgia, 30318
United States
Renew Health Clinical Research
Snellville, Georgia, 30078
United States
MetroMed Clinical Trials
Chicago, Illinois, 60614
United States
AMR Convention Research
Warrenville, Illinois, 60555
United States
Benchmark Research
Shreveport, Louisiana, 71101
United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877
United States
Copley Clinical
Boston, Massachusetts, 02116
United States
Boston Clinical Trials
Roslindale, Massachusetts, 02131
United States
Adams Clinical
Watertown, Massachusetts, 02471
United States
Vitalix Clinical
Worcester, Massachusetts, 01608
United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
United States
Integrative Clinical Trials
Brooklyn, New York, 11229
United States
Basil Clinical
Inwood, New York, 11096
United States
Berman Clinical
New York, New York, 10029
United States
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
United States
The Medical Research Network, LLC
New York, New York, 10128
United States
Patient Priority Clinical Studies LLC
Cincinnati, Ohio, 45215
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73116
United States
Suburban Research Associates
West Chester, Pennsylvania, 19380
United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
United States
Donald J. Garcia, Jr., MD, PA
Austin, Texas, 78737
United States
Community Clinical Research, Inc.
Austin, Texas, 78754
United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251
United States
North Texas Clinical Trials
Fort Worth, Texas, 76104
United States
DM Clinical Research - Belliare
Houston, Texas, 77081
United States
Psychiatric And Behavioral Solutions, LLC
Millcreek, Utah, 84124
United States
Core Clinical Research
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-09
Study Completion Date2025-11-13

Study Record Updates

Study Start Date2022-11-09
Study Completion Date2025-11-13

Terms related to this study

Keywords Provided by Researchers

  • MDD
  • SEP-363856
  • Antidepressant Therapy
  • ADT
  • Depression
  • Depressive Disorder
  • Major Mood Disorders
  • Mental Disorders

Additional Relevant MeSH Terms

  • Major Depressive Disorder