Overview

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

Status:
Not yet recruiting
Trial end date:
2024-07-24
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunovion
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.