A Trial of the Safety and Efficacy of SEP-363856 in the T... | NCT05593029

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 9, 2022Actual

Primary Completion Date

Nov 6, 2025Actual

Completion Date

Nov 13, 2025Actual

First Submitted Date

Oct 10, 2022

First Submission Date that Met QC Criteria

Oct 20, 2022

First Posted Date

Oct 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

929Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEP-363856 & ADT (Antidepressant Therapy)	Experimental		Drug: SEP-363856
Placebo & ADT (Antidepressant Therapy)	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SEP-363856	Drug	Tablet	SEP-363856 & ADT (Antidepressant Therapy)
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From baseline to week 14

Secondary Outcomes

Measure	Description	Time Frame
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.	From baseline to week 14

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Scottsdale Clinical Research

Label	URL
Otsuka Clinical Trials Website	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

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

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression
D003866	Depressive Disorder
D001523	Mental Disorders

ID	Term
D019964	Mood Disorders
D001526	Behavioral Symptoms
D001519	Behavior