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Dopamine D2 Receptor Modulator

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 12
Awards & highlights

Study Summary

This trial will test a new anti-schizophrenia drug in both men and women, 18-65yo, across 24 sites in North America for up to 12 weeks.

Who is the study for?
This trial is for men and women aged 18-65 with stable schizophrenia, who've been on a steady oral antipsychotic regimen for at least 6 weeks but need to switch due to side effects or insufficient results. Participants must not be at self-harm risk, pregnant, drug-abusing, or have major psychiatric disorders other than schizophrenia.Check my eligibility
What is being tested?
The study tests SEP-363856's effectiveness and safety in patients with schizophrenia switching from their current medication. It involves around 24 North American sites and lasts up to 12 weeks.See study design
What are the potential side effects?
While the specific side effects of SEP-363856 are not listed here, common antipsychotic medication side effects can include drowsiness, weight gain, dry mouth, restlessness, and sometimes more serious conditions like movement disorders or metabolic changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)
Secondary outcome measures
Percentage of subjects who discontinue for any reason (ie, all causes for 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
SEP-363856 flexibly dosed
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
50,595 Total Patients Enrolled
45 Trials studying Schizophrenia
9,219 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,600 Total Patients Enrolled
45 Trials studying Schizophrenia
9,219 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,662 Total Patients Enrolled
14 Trials studying Schizophrenia
2,641 Patients Enrolled for Schizophrenia

Media Library

SEP-363856 (Dopamine D2 Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05628103 — Phase 3
Schizophrenia Research Study Groups: SEP-363856
Schizophrenia Clinical Trial 2023: SEP-363856 Highlights & Side Effects. Trial Name: NCT05628103 — Phase 3
SEP-363856 (Dopamine D2 Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628103 — Phase 3
Schizophrenia Patient Testimony for trial: Trial Name: NCT05628103 — Phase 3

Frequently Asked Questions

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

Does this trial necessitate a participant to be under 85 years of age?

"According to the study's eligibility criteria, only those between 18 and 65 are qualified for participation. For patients outside this age range, respectively 45 and 166 trials may be an option."

Answered by AI

Are there any openings for volunteers in this medical experiment?

"Clinicaltrials.gov confirms that this trial is actively recruiting patients, with the initial posting being on December 19th 2022 and most recently updated January 3rd 2023."

Answered by AI

What are the known risks associated with SEP-363856?

"In our assessment, SEP-363856 was assigned a safety rating of 3 due to the existence of prior clinical evidence supporting efficacy and multiple rounds exhausting its safety profile."

Answered by AI

To what extent are medical centers administering this trial?

"Presently, the trial is being held in 9 centres located throughout Garden Grove, Riverside and Santee as well as other cities. Choosing a site close to your residence will be beneficial for reducing travel needs if you decide to join this study."

Answered by AI

What is the current capacity for enrolment in this clinical trial?

"Sunovion, the sponsor of this investigation, has determined that 120 individuals meeting their inclusion criteria must be enrolled for a successful trial. Collaborative Neuroscience Research LLC in Garden Grove and Clinical Innovations Inc in Riverside are two sites where Sunovion will recruit participants."

Answered by AI

To what demographic can this trial's participants belong?

"This medical trial is seeking to recruit 120 individuals with schizophrenia, aged between 18 and 65. To be considered a viable candidate the following criteria must be met: Including but not limited to being of both genders, satisfying DSM-5 diagnostic requirements for schizophrenia, demonstrating clinical stability over 8 weeks prior to commencement, suitable for switching current antipsychotic medication due to safety or efficacy issues and having been on their existing oral medication regimen for 6 weeks preceding screening."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
ProScience Research Group
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

How much does it pay. I have a good medication but would like to try something new as well.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
2022. "A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05628103.
All > Schizophrenia
~19 spots leftby Jul 2024
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