Phase 3 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old at the time of signing the consent form.
• People who have a reliable person in their life (such as a caregiver, family member, friend, case worker, or residential staff member) who can provide information about them.
• People who are currently experiencing a sudden worsening or return of symptoms that began no more than 2 months before the screening visit, and who need to be admitted to hospital for this — or, if already in hospital at screening, have been there for less than 2 weeks for this current episode.
• People who are showing a significant worsening of psychotic symptoms and a marked decline in their usual functioning, confirmed by specific assessment scores at both the screening and baseline visits (confirm with trial site for details on these scores).
• People who have previously been treated with antipsychotic medication as an outpatient, at a recommended dose and for at least 6 weeks, and who responded well to that treatment in the past.

Who may not be able to join:

• People who are sexually active or could become pregnant and do not agree to use 2 sponsor-approved methods of contraception, or remain abstinent, throughout the trial and for 30 days after the last dose of the study drug.
• People who have a current diagnosis, or symptoms consistent with a diagnosis, of a mental health condition other than schizophrenia, as defined by standard diagnostic guidelines.
• People who have spent more than 30 days in total in a psychiatric hospital during the 90 days before the screening visit.
• People who have previously received the study drug SEP-363856, or who have previously taken part in a clinical trial involving SEP-363856.

Important: Always verify eligibility with the trial site directly before applying.