This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05593029
Recruitment Status : Recruiting
First Posted : October 25, 2022
Last Update Posted : March 13, 2024
Sponsor:
Collaborators:
Sumitomo Pharma Co., Ltd.
Sumitomo Pharma America, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SEP-363856 Other: Placebo Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 9, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: SEP-363856 & ADT (Antidepressant Therapy) Drug: SEP-363856
Tablet
Placebo Comparator: Placebo & ADT (Antidepressant Therapy) Other: Placebo
Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: From baseline to week 14 ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05593029


Contacts
Layout table for location contacts
Contact: Otsuka Call Center Call Center 844-687-8522 OtsukaUS@druginfo.com

Locations
Layout table for location information
United States, New York
For additional information regarding sites, contact 844-687-8522 Recruiting
New York, New York, United States, 10001
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sumitomo Pharma Co., Ltd.
Sumitomo Pharma America, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT05593029    
Other Study ID Numbers: 382-201-00001
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
URL: http://clinical-trials.otsuka.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
MDD
SEP-363856
Antidepressant Therapy
ADT
 Depression
Depressive Disorder
Major Mood Disorders
Mental Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms