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
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria: This list is not all inclusive Male or female subject between 18 to 65 years of age. Subject meets DSM-5 criteria for a diagnosis of schizophrenia. Subject is 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. Subject 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. Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening. Exclusion Criteria:This list is not all inclusive Subject 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. Subject is at significant risk of harming self or others based on investigator's judgment. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. Female subject who is pregnant or lactating. Subject tests positive for drugs of abuse at Screening.
Sites / Locations
- Advanced Research Center, Inc.Recruiting
- Clinical Innovations Inc.Recruiting
- ProScience Research GroupRecruiting
- Collaborative Neuroscience Research, LLCRecruiting
- Synergy San DiegoRecruiting
- Clinical Innovations, IncRecruiting
- California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)Recruiting
- CMB Clinical TrialsRecruiting
- Cenexel CNS ResearchRecruiting
- Larkin Behavioral Health ServicesRecruiting
- Behavioral Clinical Research, IncRecruiting
- Premier Clinical Research Institute, Inc.Recruiting
- Nova Psychiatry, Inc.Recruiting
- Advanced Discovery Research LLCRecruiting
- Atlanta Center for Medical ResearchRecruiting
- Atlanta Behavioral ResearchRecruiting
- Uptown ResearchRecruiting
- CBH HealthRecruiting
- PsychCare Consultants ResearchRecruiting
- Hassman Research InstituteRecruiting
- New Hope Clinical ResearchRecruiting
- Clinical Trials of America, LLCRecruiting
- Charak Clinical Research CenterRecruiting
- Pillar Clinical Research, LLCRecruiting
Arms of the Study
Arm 1
Experimental
SEP-363856
SEP-363856 flexibly dosed