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Unknown

SEP-363856 for Schizophrenia

Phase 1
Waitlist Available
Research Sponsored by Sunovion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subject between 18 and 65 years of age at the time of informed consent
Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to10 weeks
Awards & highlights

Study Summary

This trial is studying a new drug for schizophrenia to see if it has physical dependence. Participants aged 18-65 are needed in 6 US sites for 10 weeks.

Who is the study for?
Adults aged 18-65 with schizophrenia, who are relatively stable (not severely ill) and have been on antipsychotic medication for at least 6 weeks can join this study. They must not be at risk of suicide or self-harm, nor have other mental health diagnoses besides schizophrenia.Check my eligibility
What is being tested?
The trial is testing SEP-363856 to see if it causes physical dependence compared to a placebo. Participants will be randomly assigned to receive either the drug or a placebo over approximately 10 weeks across six sites in the US.See study design
What are the potential side effects?
Potential side effects are not detailed here, but generally, antipsychotics can cause drowsiness, weight gain, dry mouth, restlessness and sometimes more serious side effects like movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I have been diagnosed with schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to10 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
Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SEP-363856Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 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
50,655 Total Patients Enrolled
45 Trials studying Schizophrenia
9,279 Patients Enrolled for Schizophrenia
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,660 Total Patients Enrolled
45 Trials studying Schizophrenia
9,279 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,722 Total Patients Enrolled
14 Trials studying Schizophrenia
2,701 Patients Enrolled for Schizophrenia

Media Library

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05848700 — Phase 1
Schizophrenia Research Study Groups: SEP-363856, Placebo
Schizophrenia Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05848700 — Phase 1
Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848700 — Phase 1

Frequently Asked Questions

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

Is the elderly population being considered for enrollment in this trial?

"In alignment with this study's inclusion requirements, participants must be of legal age and not exceed 65 years old."

Answered by AI

Does my profile meet the criteria for this research endeavor?

"Eligible participants for this research must have a diagnosis of schizophrenia, be between 18 and 65 years old, and the total number to be recruited is 60."

Answered by AI

Has SEP-363856 obtained the authorization of the Food and Drug Administration?

"The safety of SEP-363856 was rated 1 as this is a Phase 1 trial, signifying the paucity of data backing both its efficacy and protection."

Answered by AI

Are there any current opportunities to join this clinical experiment?

"Per the data on clinicaltrials.gov, this particular trial is not presently recruiting participants. The study was unveiled on June 30th 2023 and has since undergone a single edit on May 31st of the same year. However, 354 other medical studies are currently looking for patient candidates at present."

Answered by AI

Who else is applying?

What site did they apply to?
Behavioral Clinical Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
~34 spots leftby Apr 2025