← Back to Search

Other

SEP-363856 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 up to week 25
Awards & highlights

Study Summary

This trial will test the safety & effectiveness of an antipsychotic medication in people with schizophrenia who switch to it from their current meds. It'll take place in 24 sites in North America, & last up to 25 weeks.

Who is the study for?
This trial is for men and women with schizophrenia who have finished the SEP361-308 study. They must not have used any psychotropic drugs other than their previous antipsychotic, allowed medications during that study, and women need a negative pregnancy test at the end of it. People can't join if they're pregnant, breastfeeding, suicidal, or show significant health issues in physical exams or drug tests at the end of SEP361-308.Check my eligibility
What is being tested?
The trial continues to assess SEP-363856's effectiveness and safety for schizophrenia patients switching from their current medication to this new one. It will take place across roughly 24 sites in North America over about 25 weeks.See study design
What are the potential side effects?
While specific side effects are not listed here, as with most antipsychotics, potential side effects may include drowsiness, weight gain, dry mouth, restlessness and possibly others depending on individual reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 25 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

Side effects data

From 2020 Phase 2 trial • 39 Patients • NCT02969369
22%
Hallucination
19%
Fall
19%
Dizziness
16%
Confusional state
13%
Nausea
9%
Somnolence
9%
Anxiety
9%
Delusion
9%
Insomnia
9%
Hypotension
6%
Fatigue
6%
Urinary tract infection
6%
Aggression
6%
Agitation
6%
Pain
6%
Hypertension
3%
Corneal abrasion
3%
Asthenia
3%
Balance disorder
3%
Hip fracture
3%
Mental disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SEP-363856

Trial Design

1Treatment groups
Experimental Treatment
Group I: SEP-363856Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SEP-363856
2016
Completed Phase 2
~850

Find a Location

Who is running the clinical trial?

SunovionLead Sponsor
191 Previous Clinical Trials
50,648 Total Patients Enrolled
45 Trials studying Schizophrenia
9,272 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,653 Total Patients Enrolled
45 Trials studying Schizophrenia
9,272 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,715 Total Patients Enrolled
14 Trials studying Schizophrenia
2,694 Patients Enrolled for Schizophrenia

Media Library

SEP-363856 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05741528 — Phase 3
Schizophrenia Research Study Groups: SEP-363856
Schizophrenia Clinical Trial 2023: SEP-363856 Highlights & Side Effects. Trial Name: NCT05741528 — Phase 3
SEP-363856 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741528 — Phase 3

Frequently Asked Questions

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

Does the study permit applicants aged eighteen and above?

"The eligibility criteria for this trial requires that participants be over 18 and no older than 65 years old."

Answered by AI

To what extent could SEP-363856 be considered a health hazard?

"Our evaluation group at Power have assigned SEP-363856 a safety rating of 3 given that the drug has been tested thoroughly in Phase III trials and its efficacy is supported by substantial data."

Answered by AI

How many locations are overseeing the management of this trial?

"At this moment in time, the trial is operational at 11 clinics located near Lemon Grove, Riverside and San Diego. To make sure that your participation does not require excessive travelling, it would be a wise choice to select the nearest site possible."

Answered by AI

Is enrollment in this experiment currently open to new participants?

"According to the information on clinicaltrials.gov, this research initiative is not currently seeking out new participants. The trial was initially posted and last updated on March 31st 2023, with no further changes since then. Although this study is paused for now, there are 339 other studies actively enrolling patients right now."

Answered by AI

Does my profile meet the requirements for participating in this experiment?

"This research study is accepting individuals with schizophrenia aged 18 and 65 into the trial. To be considered, applicants must fulfil several criteria including: providing written consent; completing a treatment period of Study SEP361-308; abstaining from psychotropic medications other than those approved for pre-switch antipsychotics or protocol allowances; and female subjects producing negative rapid urine pregnancy tests at the End of Treatment (EOT) Visit of Study SEP361-308."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
2023. "An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741528.
~26 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top