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SEP-363856 for Depression

Verified Trial
Phase 2 & 3
Recruiting
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Subjects with a current diagnosis of a cognitive, psychotic, bipolar, eating, obsessive-compulsive, panic, post-traumatic stress, or personality disorder
Have had history of eating disorder, deep brain simulation, bi-polar disorder, schizophrenia, PTSD, OCD, or borderline personality disorder?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 14
Awards & highlights

Study Summary

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

Who is the study for?
Adults aged 18-65 with major depressive disorder (MDD) who are currently experiencing a depressive episode and have had an inadequate response to 1-3 antidepressant treatments. The current episode should be at least 8 weeks but no more than 2 years long. Participants must not have certain other mental health disorders or be unwilling to use approved birth control methods if they can become pregnant.Check my eligibility
What is being tested?
This trial is testing the safety and effectiveness of SEP-363856 as an additional treatment for MDD in adults. It's a randomized, double-blind study comparing flexible doses of SEP-363856 against a placebo to see which works better.See study design
What are the potential side effects?
While specific side effects for SEP-363856 aren't listed here, common side effects from similar medications may include nausea, headache, sleep disturbances, sexual dysfunction, fatigue, dry mouth, blurred vision or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My current major depressive episode has lasted between 8 weeks and 2 years.
Select...
I've tried 1-3 antidepressants without enough improvement.
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You currently have a diagnosed mental health condition such as bipolar disorder, eating disorder, or PTSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery Åsberg Depression Rating Scale (MADRS)
Secondary outcome measures
Clinical Global Impression - Severity of Illness (CGI-S)

Side effects data

From 2020 Phase 2 trial • 39 Patients • NCT02969369
22%
Hallucination
19%
Fall
19%
Dizziness
16%
Confusional state
13%
Nausea
9%
Somnolence
9%
Anxiety
9%
Delusion
9%
Insomnia
9%
Hypotension
6%
Fatigue
6%
Urinary tract infection
6%
Aggression
6%
Agitation
6%
Pain
6%
Hypertension
3%
Corneal abrasion
3%
Asthenia
3%
Balance disorder
3%
Hip fracture
3%
Mental disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SEP-363856

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856 & ADT (Antidepressant Therapy)Experimental Treatment1 Intervention
Group II: Placebo & ADT (Antidepressant Therapy)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
2016
Completed Phase 2
~850

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
246 Previous Clinical Trials
166,149 Total Patients Enrolled
28 Trials studying Depression
39,319 Patients Enrolled for Depression
Sumitomo Pharma America, Inc.Industry Sponsor
236 Previous Clinical Trials
51,820 Total Patients Enrolled
19 Trials studying Depression
5,557 Patients Enrolled for Depression
Sumitomo Pharma Co., Ltd.Industry Sponsor
27 Previous Clinical Trials
4,990 Total Patients Enrolled
1 Trials studying Depression
525 Patients Enrolled for Depression

Media Library

SEP-363856 & ADT (Antidepressant Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05593029 — Phase 2 & 3
Depression Research Study Groups: Placebo & ADT (Antidepressant Therapy), SEP-363856 & ADT (Antidepressant Therapy)
Depression Clinical Trial 2023: SEP-363856 & ADT (Antidepressant Therapy) Highlights & Side Effects. Trial Name: NCT05593029 — Phase 2 & 3
SEP-363856 & ADT (Antidepressant Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05593029 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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

"This particular clinical trial, as stated on clinicaltrials.gov, 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Research Site - Shreveport, LA
For additional information regarding sites, contact 844-687-8522

Why did patients apply to this trial?

I've tried more then 5 drugs for depression and it's very depressing frustrating when they do not work, or even help nothing, I'm still looking for that one or 2 that will help.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Research Site - Shreveport, LA: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
2022. "A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05593029.
All > Mdd
~372 spots leftby May 2025
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