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Investigational Drug for Bipolar Depression

Verified Trial
Phase 3
Recruiting
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
Timeline
Screening 1 day
Treatment 8 weeks
Follow Up 1 months
Awards & highlights

Study Summary

This trial is testing whether an investigational drug is effective and safe for treating bipolar I depression. The trial will be conducted in the US, Europe, Latin America, and Japan, with both male and female participants ages 18-65. Participation will last approximately 10 weeks.

Who is the study for?
This trial is for adults aged 18-65 with Bipolar I disorder currently experiencing a major depressive episode. They should be in good health, have specific scores on depression and mania rating scales, and not be undergoing treatment for any other primary psychiatric condition.Check my eligibility
What is being tested?
The study tests the effectiveness of SEP-4199 CR at two different doses (200 mg and 400 mg) compared to a placebo in treating bipolar depression. Participants will randomly receive either the drug or placebo across various global sites over approximately 10 weeks.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions associated with antidepressant medications such as nausea, headache, sleep disturbances, weight changes, or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current major depressive episode has lasted more than 4 weeks but less than a year.
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I am between 18 and 65 years old.
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My current major depressive episode has lasted more than 4 weeks but less than 12 months.
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I am in good health as confirmed by recent medical exams and tests.

Timeline

Screening ~ 1 day
Treatment ~ 8 weeks
Follow Up ~1 months
This trial's timeline: 1 day for screening, 8 weeks for treatment, and 1 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary outcome measures
Change from Baseline to Week 6 in Clinical Global Impressions-Severity: Bipolar Version (CGI-BP-S) depression score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-4199 CR 400 mgExperimental Treatment1 Intervention
SEP-4199 CR 400 mg/day
Group II: SEP-4199 CR 200 mgExperimental Treatment1 Intervention
SEP-4199 CR 200 mg/day
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,198 Total Patients Enrolled
SunovionLead Sponsor
191 Previous Clinical Trials
50,193 Total Patients Enrolled
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,260 Total Patients Enrolled

Media Library

SEP-4199 CR 200 mg (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05169710 — Phase 3
Bipolar Depression Research Study Groups: SEP-4199 CR 200 mg, Placebo, SEP-4199 CR 400 mg
Bipolar Depression Clinical Trial 2023: SEP-4199 CR 200 mg Highlights & Side Effects. Trial Name: NCT05169710 — Phase 3
SEP-4199 CR 200 mg (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169710 — Phase 3
Bipolar Depression Patient Testimony for trial: Trial Name: NCT05169710 — Phase 3

Frequently Asked Questions

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

Are there any qualifiers to joining this particular clinical trial?

"522 individuals aged 18-65 who suffer from melancholia and meet the following additional criteria are eligible for enrolment in this study. These patients must have had their current major depressive episode for at least 4 weeks but no longer than 12 months, a MADRS score of ≥22 at Screening and Baseline, a CGI-BP-S depression score of ≥4 at Screening and Baseline, and a YMRS total score of ≤12 at Screening and Baseline."

Answered by AI

Are there any additional places open for participants in this research?

"This trial is currently seeking candidates, as reported on clinicaltrials.gov. The study was initially posted on December 21, 2021 and was last edited on November 1, 2022."

Answered by AI

What are the risks associated with taking SEP-4199 CR 200 mg?

"There is some evidence indicating that SEP-4199 CR 200 mg is effective, and multiple rounds of data support its safety. Therefore, our team at Power has given it a score of 3."

Answered by AI

Does the age limit for this clinical trial stop at 85 years old?

"In order to be eligible for this trial, potential participants must fall in the age bracket of 18 to 65 years old. Out of the 1287 total clinical trials, 204 are for individuals under 18 and 989 are for those over 65."

Answered by AI

Are there a few research facilities within the US testing this hypothesis?

"There are currently 15 sites running this study. To limit participant's travel burden, it is best to choose the clinic nearest your location from the list of 15 options."

Answered by AI

Who else is applying?

What state do they live in?
New York
Alabama
Other
Texas
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham Huntsville Regional Medical Campus
Community Clinical Research, Inc.
UTHealth Science Center at Houston
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+

What questions have other patients asked about this trial?

What is meant by prior treatment? Do we get any compensation for doing the trial like money wise I mean and if so, how much and how often?
PatientReceived 1 prior treatment
How often do I have to come to screening visits and how long do they last? How much is compensation and when will I get compensation?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Trying to get effective help. I am currently taking Vraylar 3mg. I'm hoping this trial will help me.
PatientReceived 2+ prior treatments
I am currently taking Vraylar 4.5mg. The drugs we have tried are not working.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Family Psychiatry of The Woodlands: < 48 hours
  2. University of Alabama at Birmingham Huntsville Regional Medical Campus: < 48 hours
  3. Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
2021. "A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169710.
All > Depression Los Angeles
~166 spots leftby May 2025
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