SEP-363856 & ADT (Antidepressant Therapy) for Depression

Phase-Based Progress Estimates
For additional information regarding sites, contact 844-687-8522, New York, NYDepressionSEP-363856 - Drug
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial tests a new drug for adults with major depressive disorder, to see if it's safe and effective.

Eligible Conditions
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: From baseline to week 14

Week 14
Clinical Global Impression - Severity of Illness (CGI-S)
Montgomery Åsberg Depression Rating Scale (MADRS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

1%Cardiovascular insufficiency
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02969382) in the SEP-363856 ARM group. Side effects include: Headache with 9%, Somnolence with 7%, Schizophrenia with 6%, Nausea with 5%, Agitation with 5%.

Trial Design

2 Treatment Groups

SEP-363856 & ADT (Antidepressant Therapy)
1 of 2
Placebo & ADT (Antidepressant Therapy)
1 of 2

Experimental Treatment

Non-Treatment Group

900 Total Participants · 2 Treatment Groups

Primary Treatment: SEP-363856 & ADT (Antidepressant Therapy) · Has Placebo Group · Phase 2 & 3

SEP-363856 & ADT (Antidepressant Therapy)
Experimental Group · 1 Intervention: SEP-363856 · Intervention Types: Drug
Placebo & ADT (Antidepressant Therapy)
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 14

Who is running the clinical trial?

Sumitomo Pharma Co., Ltd.Industry Sponsor
27 Previous Clinical Trials
5,552 Total Patients Enrolled
1 Trials studying Depression
525 Patients Enrolled for Depression
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
244 Previous Clinical Trials
163,792 Total Patients Enrolled
28 Trials studying Depression
39,319 Patients Enrolled for Depression
SunovionIndustry Sponsor
190 Previous Clinical Trials
47,695 Total Patients Enrolled
20 Trials studying Depression
8,348 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have been experiencing a major depressive episode, it must have lasted between 8 weeks and 2 years.
You have been diagnosed with depression and have tried up to three different antidepressant treatments without success.

Frequently Asked Questions

Are people with the required qualifications currently being sought for this research project?

"This particular clinical trial, as stated on, is no longer recruiting patients. The trial was originally posted on November 8th, 2020 and was last edited on November 2nd, 2020. There are, however, 2103 other studies that are actively recruiting patients." - Anonymous Online Contributor

Unverified Answer

If a patient is outside of the target age group, will they still be able to participate in this research?

"The age requirements for this particular clinical trial are between 18 to 65 years old. Out of the 1488 trials for patients over 65 and the 423 trials for patients under 18, this is the only one that they may be eligible for." - Anonymous Online Contributor

Unverified Answer

Who would be able to enroll and participate in this clinical trial?

"To be included in this study, which is investigating major depressive disorder, participants must be between 18-65 years old, have a primary diagnosis of MDD, and be in their current major depressive episode for 8 weeks to 2 years. Additionally, participants must have had an inadequate response to 1-3 antidepressant treatments in their current major depressive episode." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.