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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily target dopamine D2 receptors to alleviate psychotic symptoms. First-generation antipsychotics (FGAs) are effective but often cause movement disorders due to strong dopamine antagonism. Second-generation antipsychotics (SGAs) also target serotonin receptors, which can reduce side effects and improve treatment of negative symptoms. SEP-363856, a novel antipsychotic, targets trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors, offering a different mechanism that may enhance efficacy and reduce side effects. This is crucial for schizophrenia patients as it can lead to better symptom management and improved quality of life.

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
237 Previous Clinical Trials
52,646 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
~22 spots leftby Jan 2025
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