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SEP-363856 75mg for Schizophrenia

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 baseline and week 6
Awards & highlights

Study Summary

This trial is testing a new drug for people with schizophrenia who are experiencing a psychotic episode. The drug will be compared to a placebo, and the study will last up to 9 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 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 in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
Secondary outcome measures
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856 75mgExperimental Treatment1 Intervention
SEP-363856 75mg dosed once daily
Group II: SEP-363856 100mgExperimental Treatment1 Intervention
SEP-363856 100mg dosed once daily
Group III: PlaceboPlacebo Group1 Intervention
Placebo dosed once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856 100mg
2019
Completed Phase 3
~470
SEP-363856 75mg
2019
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,251 Total Patients Enrolled
45 Trials studying Schizophrenia
8,875 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,256 Total Patients Enrolled
45 Trials studying Schizophrenia
8,875 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,318 Total Patients Enrolled
14 Trials studying Schizophrenia
2,297 Patients Enrolled for Schizophrenia

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04092686 — Phase 3
Schizophrenia Research Study Groups: SEP-363856 75mg, Placebo, SEP-363856 100mg
Schizophrenia Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04092686 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092686 — Phase 3

Frequently Asked Questions

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

Would it be possible to enroll in this research project at this time?

"This study, which is currently recruiting participants, was first posted on September 30th 2019. The last update to the listing was on September 30th 2022."

Answered by AI

Are there numerous research facilities in Canada who are administering this trial?

"At the moment, patients can be enrolled at Atlanta Center for Medical Research in Atlanta, Georgia; Pillar Clinical Research in Chicago, Illinois; or Woodland International Research Group in Little Rock, Arkansas. There are 20 other locations listed on the study's website."

Answered by AI

Are the only participants in this study adults?

"The age restrictions for this study are individuals who are 18 years old or younger and 65 years old or older."

Answered by AI

Has the FDA cleared SEP-363856 75mg for public consumption?

"There is some clinical data supporting the efficacy of SEP-363856 75mg, and it has been through multiple rounds of safety testing, so we give it a score of 3."

Answered by AI

How many people are chosen to participate in this research?

"In order to move forward with the study, 462 patients that meet the inclusion criteria must be enrolled. The trial will be conducted by Sunovion at multiple sites; for example, Atlanta Center for Medical Research in Atlanta, Georgia and Pillar Clinical Research in Chicago, Illinois."

Answered by AI

To your knowledge, has research like this been conducted before?

"Research into SEP-363856 75mg began in 2019, with the earliest study being completed that same year and sponsored by Sunovion. After the initial trial involving 22 participants, SEP-363856 75mg received Phase 1 drug approval. There are currently 6 live studies for SEP-363856 75mg across 64 cities and 9 countries."

Answered by AI

How can I sign up for this opportunity to help with this research?

"Eligibility for this clinical trial is restricted to those with a diagnosis of schizophrenia that are also between 18-65 years old. A total of 462 individuals will be accepted."

Answered by AI

Are there other similar instances of SEP-363856 75mg being used in medical trials?

"SEP-363856 75mg was first studied in 2019 at King's College London. As of right now, there have been 18294 completed trials and 6 more that are actively recruiting patients. The majority of these studies are based in Atlanta, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Maine
Tennessee
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Precise Research Centers
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
2019. "A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092686.
~84 spots leftby Apr 2025
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