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Not Yet Recruiting NCT05741528

An Extension Study to a Clinical Study That Will Continue to Evalute the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antisychotic Medication

Conditions: Schizophrenia

Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 67
Sponsor: Sunovion

Summary

An Extension study to a clinical study that will continue to evalute the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their from their current antisychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in appoximately 24 study sites in North America. Particiaption in the study will be approximately up to 25 weeks.

Eligibility Criteria

Inclusion Criteria: (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.Exclusion Criteria: (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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05741528). StuddyBuddy aggregates publicly available trial information.