An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
- Registration Number
- NCT05741528
- Brief Summary
An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.
- Detailed Description
This is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed Study SEP361-308 treatment period, during which they were switched from a previous antipsychotic treatment to SEP-363856.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
(list is not all inclusive)
- Subject has given written informed consent and privacy authorization prior to participation in the study.
- Subject has completed the Treatment Period of Study SEP361-308.
- Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
- Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
(list is not all inclusive)
- Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
- Female subject is pregnant or lactating.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SEP-363856 SEP-363856 -
- Primary Outcome Measures
Name Time Method The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation up to week 25
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Richardson, Texas, United States
Research Site🇺🇸Richardson, Texas, United States