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

• Status: Not yet recruiting
• Trial end date: 2025-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion

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.