A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Inclusion Criteria:

• Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2
• Meets criteria for the diagnosis of schizophrenia
• Resides in a stable living situation when not hospitalized
• Is willing and able to provide government-issued identification
• Additional criteria may apply

Exclusion Criteria:

• Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
• Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
• Subject poses a current suicide risk
• Subject has a history of treatment resistance
• Subject has a history of poor or inadequate response to treatment with olanzapine
• Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
• Subject has a diagnosis of moderate or severe alcohol or drug use disorder
• Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
• Additional criteria may apply