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SEP-4199 CR for Bipolar I Depression

Phase 3
Waitlist Available
Research Sponsored by Sunovion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial is to study the safety and tolerability of a new drug for people with Bipolar I Depression. It is a year-long study being conducted at 90 centers worldwide.

Eligible Conditions
  • Bipolar Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation

Trial Design

1Treatment groups
Experimental Treatment
Group I: SEP-4199 CRExperimental Treatment1 Intervention
SEP-4199 CR either 200 mg (one 200 mg tablet) or 400 mg (two 200 mg tablets) once daily

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,692 Total Patients Enrolled
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,728 Total Patients Enrolled
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,759 Total Patients Enrolled

Media Library

SEP-4199 CR (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05227209 — Phase 3
Bipolar Depression Research Study Groups: SEP-4199 CR
Bipolar Depression Clinical Trial 2023: SEP-4199 CR Highlights & Side Effects. Trial Name: NCT05227209 — Phase 3
SEP-4199 CR (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227209 — Phase 3

Frequently Asked Questions

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

Does this experiment only use elderly test subjects?

"The age range for participants in this trial are those aged 18 to 65."

Answered by AI

What is the SEP-4199 CR FDA approval status?

"There is some evidence from prior clinical trials to support the efficacy of SEP-4199 CR, and it has thus been given a safety rating of 3."

Answered by AI

Are there still places available for participants in this experiment?

"This particular clinical trial, which was first made public on March 17th 2022 is not recruiting patients at this moment. The last update to the study's page on clinicaltrials.gov occurred on November 1st of the same year. Although this specific study isn't looking for volunteers presently, there are many other trials (1,350 in total) that are actively searching for candidates right now."

Answered by AI

Is this research project being conducted at multiple sites within the United States?

"There are a total of 13 different clinical trial sites recruiting patients for this study, with locations inJacksonville, Orlando, Lincoln and 10 other cities. To minimize travel requirements, it is best to select the nearest location to you."

Answered by AI

Who would be an ideal candidate for this clinical trial?

"This clinical trial is looking for 355 participants who have melancholia and meet the following additional inclusion criteria: between 18-65 years old, female subjects must be willing to use contraception throughout the study and for 30 days after taking the last dose of medication, agree to comply with the protocol, completed 6 weeks of double-blind treatment from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR, appropriate for long-term open-label treatment with SEP-4199 CR, male subjects agree to avoid fathering a child and use birth control methods throughout the study until 90 days after taking"

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Clinical Neuroscience Solutions, Inc.
Alivation Research, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

My ex girl friend did a trail.
PatientReceived 1 prior treatment
~21 spots leftby Mar 2025