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Unknown

SEP-363856 for Schizophrenia

Phase 1
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 up to 8 weeks
Awards & highlights

Study Summary

This trial looks at whether a new medication affects body weight in people with schizophrenia, ages 18-65. Participation could last up to 13 weeks, and takes place in 6 US sites.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia, currently treated with risperidone, olanzapine, quetiapine or aripiprazole. Participants should have mild to moderate symptoms without recent suicide attempts or risk of harm as judged by the investigator.Check my eligibility
What is being tested?
The study tests SEP-363856 against standard antipsychotics (risperidone, olanzapine, quetiapine or aripiprazole) to see its effects on body weight in schizophrenia patients over up to 13 weeks at about six US sites.See study design
What are the potential side effects?
Potential side effects may include changes in weight and appetite, sleep disturbances, gastrointestinal issues like nausea or constipation, and possible mood swings or agitation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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
Change in Liver Fibroinflammation, baseline to end of the treatment
Change in Liver Volume from baseline to end of treatment
Change in fat content in muscles of interest, baseline to end of the treatment
+3 more

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
Active Control
Group I: SEP-363856Experimental Treatment1 Intervention
Group II: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)Active Control1 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?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,701 Total Patients Enrolled
45 Trials studying Schizophrenia
9,320 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
191 Previous Clinical Trials
50,696 Total Patients Enrolled
45 Trials studying Schizophrenia
9,320 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,763 Total Patients Enrolled
14 Trials studying Schizophrenia
2,742 Patients Enrolled for Schizophrenia

Media Library

SEP-363856 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05542264 — Phase 1
Schizophrenia Research Study Groups: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole), SEP-363856
Schizophrenia Clinical Trial 2023: SEP-363856 Highlights & Side Effects. Trial Name: NCT05542264 — Phase 1
SEP-363856 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05542264 — Phase 1
Schizophrenia Patient Testimony for trial: Trial Name: NCT05542264 — Phase 1

Frequently Asked Questions

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

What is the current enrollment rate for this research project?

"Correct. According to clinicaltrials.gov, this trial is actively seeking volunteers for participation and was initially posted on November 15th 2022. Last edited on the 21st of that same month, it requires 60 participants from 2 distinct sites."

Answered by AI

Is this particular research initiative currently accepting new participants?

"The information found on clinicaltrials.gov specifies that this ongoing medical trial is in need of participants, having been posted on November 15th 2022 and edited most recently on the 21st."

Answered by AI

Is eligibility for this trial restricted to participants under the age of 50?

"This research seeks adults aged 18-65 to participate in the trial."

Answered by AI

What precautions should be taken when administering SEP-363856 to individuals?

"Taking into account the limited clinical data available, our team at Power has assessed that SEP-363856 is safe enough to receive a score of 1. This evaluation was based off its status as a Phase 1 trial."

Answered by AI

What qualifications are needed to partake in this clinical research?

"This clinical trial is looking for 60 participants with schizophrenia, aged between 18 and 65. To be eligible to take part in this research project, potential candidates must meet the following criteria: possess a DSM-5 diagnosis of schizophrenia established by a clinical interview; receive risperidone, olanzapine, quetiapine or aripiprazole as treatment for their disorder at screening; have PANSS total score ≤ 80 and scores on P7 (hostility) and G8 (uncooperativeness) items that are lower than 4 respectively; show CGI-S score equal to or below 4 during screening."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Midwest Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I need help.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia
2022. "A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05542264.
~8 spots leftby Apr 2025
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