A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SEP-363856
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, SEP-363856, Antidepressant Therapy, ADT, Depression, Depressive Disorder, Major Mood Disorders, Mental Disorders
Eligibility 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 current diagnosis of a cognitive, psychotic, bipolar, eating, obsessive-compulsive, panic, post-traumatic stress, or personality disorder
- 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.
Sites / Locations
- For additional information regarding sites, contact 844-687-8522Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SEP-363856 & ADT (Antidepressant Therapy)
Placebo & ADT (Antidepressant Therapy)
Arm Description
Outcomes
Primary Outcome Measures
Montgomery Åsberg Depression Rating Scale (MADRS)
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
Clinical Global Impression - Severity of Illness (CGI-S)
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.
Full Information
NCT ID
NCT05593029
First Posted
October 10, 2022
Last Updated
August 31, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Sumitomo Pharma Co., Ltd., Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05593029
Brief Title
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Sumitomo Pharma Co., Ltd., Sumitomo Pharma America, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, SEP-363856, Antidepressant Therapy, ADT, Depression, Depressive Disorder, Major Mood Disorders, Mental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SEP-363856 & ADT (Antidepressant Therapy)
Arm Type
Experimental
Arm Title
Placebo & ADT (Antidepressant Therapy)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
Tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
From baseline to week 14
Secondary Outcome Measure Information:
Title
Clinical Global Impression - Severity of Illness (CGI-S)
Description
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.
Time Frame
From baseline to week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Otsuka Call Center Call Center
Phone
844-687-8522
Email
OtsukaUS@druginfo.com
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
http://clinical-trials.otsuka.com
Learn more about this trial
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
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