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SEP363856 for Schizophrenia

Phase 3
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial is testing an investigational drug for people with schizophrenia to see if it is safe and tolerable in the long term.

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 (SAEs), and Adverse Events (AEs) leading to discontinuation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SEP363856Experimental Treatment1 Intervention
SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule
Group II: quetiapine XRActive Control1 Intervention
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP363856
2019
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,245 Total Patients Enrolled
45 Trials studying Schizophrenia
8,864 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
191 Previous Clinical Trials
50,240 Total Patients Enrolled
45 Trials studying Schizophrenia
8,864 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,307 Total Patients Enrolled
14 Trials studying Schizophrenia
2,286 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.

What makes this research unique when compared to others in the field?

"SEP363856 is being trialed in 27 countries and 171 cities. The first study was completed in 2014 with 200 patients. Otsuka America Pharmaceutical sponsored the initial study, which completed Phase 4 drug approval. In the 6 years since, 186 more trials have been conducted."

Answered by AI

Is this study only for people who are over 60 years old?

"The age restriction for potential participants in this study is between 18 and 65 years old."

Answered by AI

What indications is SEP363856 most effective for?

"SEP363856 is a medication with multiple purposes, such as treating anxiety and bipolar disorder, as well as more acute medical concerns like coryza and depression."

Answered by AI

What is the present status of SEP363856 in regards to federal sanctioning?

"There is existing clinical data that SEP363856 is safe for use, as seen by its Phase 3 classification."

Answered by AI

Are there any previous scientific papers which mention SEP363856?

"There are a total of 18 active clinical trials for SEP363856. Of those, 7 are in Phase 3. The majority of trials for this drug are based in Bhubaneswar, Orissa, but there are 641 total locations running trials."

Answered by AI

Are there different research facilities conducting this trial throughout North America?

"There are currently 17 enrolment sites for this study, including Innovative Clinical Research in Miami Lakes, Krzsztof Wroblewi-Neurobehavioral Research Inc. in Cedarhurst, and Louisiana Clinical Research in Shreveport."

Answered by AI

Is this a closed or open trial in terms of patient recruitment?

"This particular trial is no longer looking for participants, as noted on clinicaltrials.gov. The date the study was first posted was November 15th, 2019 and the last update to the site was February 16th, 2022. There are, however, 363 other trials that are still recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Georgia
How old are they?
18 - 65
What site did they apply to?
Synexus Clinical Research US
Dean-Yurie, Altea Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
2019. "A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04115319.
~88 spots leftby Apr 2025
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