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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
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 moreSide effects data
From 2020 Phase 2 trial • 39 Patients • NCT0296936922%
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 3
~950
Find a Location
Who is running the clinical trial?
Sumitomo Pharma America, Inc.Lead Sponsor
237 Previous Clinical Trials
52,675 Total Patients Enrolled
45 Trials studying Schizophrenia
9,301 Patients Enrolled for Schizophrenia
SunovionLead Sponsor
191 Previous Clinical Trials
50,677 Total Patients Enrolled
45 Trials studying Schizophrenia
9,301 Patients Enrolled for Schizophrenia
CNS Medical DirectorStudy ChairSumitomo Pharma America, Inc.
33 Previous Clinical Trials
6,744 Total Patients Enrolled
14 Trials studying Schizophrenia
2,723 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a mental health condition, but it's not schizophrenia or intellectual disability.I am currently taking medication for schizophrenia.I am between 18 and 65 years old.My mental health score is 80 or less, with specific conditions met.I have been diagnosed with schizophrenia according to DSM-5 criteria.These are not all the requirements to be included in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
- Group 2: SEP-363856
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05542264 — Phase 1
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