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

Sumitomo Pharma

Status and phase

Invitation-only

Phase 3

Conditions

Schizophrenia

Treatments

Drug: SEP-363856

Study type

Interventional

Funder types

Industry

Identifiers

NCT05741528

SEP361-309

Details and patient eligibility

About

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. 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.

Full 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.

Enrollment

67 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.