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
- Registration Number
- NCT05628103
- Brief Summary
This study 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.
- Detailed Description
This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.
Following a screening period of up to 21 days, eligible participants will take part in the study. In the 8-week treatment period, participants will be treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants will be required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
This list is not all inclusive
- Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
- Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
- Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
- Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
This list is not all inclusive
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
- Participants are at significant risk of harming self or others based on investigator's judgment.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
- Female participant who is pregnant or lactating.
- Participant tests positive for drugs of abuse at Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SEP-363856 SEP-363856 Participants will receive flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose will be titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose will be adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.
- Primary Outcome Measures
Name Time Method Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy) Up to Week 12
- Secondary Outcome Measures
Name Time Method Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation) Up to Week 12
Trial Locations
- Locations (25)
Clinical Innovations, Inc
🇺🇸Riverside, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
🇺🇸San Diego, California, United States
Cenexel CNS Research
🇺🇸Torrance, California, United States
Larkin Behavioral Health Services
🇺🇸Hollywood, Florida, United States
Premier Clinical Research Institute, Inc.
🇺🇸Miami, Florida, United States
Wellness Research Center
🇺🇸Miami, Florida, United States
Advanced Discovery Research LLC
🇺🇸Atlanta, Georgia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Uptown Research
🇺🇸Chicago, Illinois, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
IMA Clinical Research
🇺🇸Las Vegas, Nevada, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Clinical Innovations Inc.
🇺🇸Bellflower, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Garden Grove, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
CMB Clinical Trials
🇺🇸Santee, California, United States
Atlanta Behavioral Research
🇺🇸Atlanta, Georgia, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Clinical Trials of America, LLC
🇺🇸Hickory, North Carolina, United States
Charak Clinical Research Center
🇺🇸Garfield Heights, Ohio, United States
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
Nova Psychiatry, Inc.
🇺🇸Orlando, Florida, United States