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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
Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
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 in a psychotic state. The drug will be given to some people, and others will receive a placebo. The study will last up to 9 weeks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The doctor has examined you and thinks you are in good health based on your medical history, physical exam, vital signs, and lab results.
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You have been diagnosed with schizophrenia by a doctor during a screening interview.
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You have experienced severe mental symptoms within the last two months.
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You have significant problems carrying out daily activities.

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 50mgExperimental Treatment1 Intervention
SEP-363856 50mg 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 50mg
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
50,252 Total Patients Enrolled
45 Trials studying Schizophrenia
8,876 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,257 Total Patients Enrolled
45 Trials studying Schizophrenia
8,876 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSunovion Pharmaceuticals In.
33 Previous Clinical Trials
6,319 Total Patients Enrolled
14 Trials studying Schizophrenia
2,298 Patients Enrolled for Schizophrenia

Frequently Asked Questions

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

Does the age limit for this trial extend to people over 75 years old?

"Eligibility for this trial requires that potential patients are aged 13-65."

Answered by AI

Are there any recorded safety concerns with SEP-363856 75mg?

"There is available clinical data that supports the safety of SEP-363856 75mg, and it thus received a score of 3."

Answered by AI

How does one go about signing up for this clinical trial?

"In order to be eligible for this clinical trial, participants must have a diagnosis of schizophrenia and fall within the age range of 13-65. The study is looking to enroll approximately 525 individuals in total."

Answered by AI

Could you provide a count of the research facilities where this trial is being conducted?

"Currently, there are 16 sites enrolling patients for this study. These locations include Atlanta, Austin and Saint Louis. To avoid excessive travel, it is best to select the clinic closest to your location."

Answered by AI

What is the projected intake for this experiment?

"Yes, the information on clinicaltrials.gov suggests that this study is actively seeking patients. The clinical trial was first posted on 9/11/2019 and was last edited on 10/14/2022. The trial is looking for 525 patients across 16 sites."

Answered by AI

What are the origins of this clinical trial?

"SEP-363856 75mg has been under investigation since 2019. The first clinical trial, which was sponsored by Sunovion and had 22 participants, occurred that year. As a result of the positive findings in the initial study, SEP-363856 75mg received Phase 1 drug approval. Currently, there are six ongoing trials involving this medication being conducted in 9 different countries and 64 cities."

Answered by AI

What similar studies have been done with SEP-363856 75mg?

"SEP-363856 75mg is currently being studied in 6 different clinical trials, 5 of which are in Phase 3. The many trials for SEP-363856 75mg are based primarily in Pazardzhik, Mississippi, although there are a total of 272 locations running studies for this treatment across the globe."

Answered by AI

Are there any unfilled vacancies for this research project?

"Yes, this trial is recruiting patients as of now. The original posting date was September 11th, 2019 with the latest update on October 14th, 2020."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Ontario
Texas
How old are they?
18 - 65
What site did they apply to?
Research Centers of America
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
2019. "A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04072354.
~83 spots leftby Apr 2025
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