A Clinical Study That Will Evalute How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antisychotic Medication
Study Details
Study Description
Brief Summary
A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antisychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SEP-363856 SEP-363856 flexibly dosed |
Drug: SEP-363856
SEP-363856 flexibly dosed
|
Outcome Measures
Primary Outcome Measures
- 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
- Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation) [Up to Week 12]
Eligibility Criteria
Criteria
Inclusion Criteria: This list is not all inclusive
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Male or female subject between 18 to 65 years of age.
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Subject meets DSM-5 criteria for a diagnosis of schizophrenia.
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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.
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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.
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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
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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.
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Subject is at significant risk of harming self or others based on investigator's judgment.
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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.
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Female subject who is pregnant or lactating.
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Subject tests positive for drugs of abuse at Screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ProScience Research Group | Culver City | California | United States | 90230 |
2 | Collaborative Neuroscience Research, LLC | Garden Grove | California | United States | 92845 |
3 | Synergy San Diego | Lemon Grove | California | United States | 91945 |
4 | Clinical Innovations, Inc | Riverside | California | United States | 92506 |
5 | California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) | San Diego | California | United States | 92102 |
6 | CMB Clinical Trials | Santee | California | United States | 92071 |
7 | Cenexel CNS Research | Torrance | California | United States | 90502 |
8 | Larkin Behavioral Health Services | Hollywood | Florida | United States | 33021 |
9 | Advanced Discovery Research LLC | Atlanta | Georgia | United States | 30318 |
10 | Atlanta Center for Medical Research | Atlanta | Georgia | United States | 30331 |
11 | Uptown Research | Chicago | Illinois | United States | 60640 |
12 | CBH Health | Gaithersburg | Maryland | United States | 20877 |
13 | Hassman Research Institute | Berlin | New Jersey | United States | 08009 |
14 | Clinical Trials of America, LLC | Hickory | North Carolina | United States | 28601 |
15 | Charak Clinical Research Center | Garfield Heights | Ohio | United States | 44125 |
Sponsors and Collaborators
- Sunovion
Investigators
- Study Chair: CNS Medical Director, Sunovion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SEP361-308