A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation

This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.

Inclusion Criteria:

• Has a diagnosis of schizophrenia
• Requires acute treatment for symptoms of schizophrenia
• Willing and able to be confined to an inpatient study unit for up to 3-4 weeks
• Has experienced at least one previous hospitalization for schizophrenia
• Has been able to achieve outpatient status for more than 3 months in the past year
• Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2
• Resides in a stable living situation when not hospitalized
• Has an identified reliable caregiver (for example, family member)
• Additional criteria may apply

Exclusion Criteria:

• Poses a current suicide risk
• Pregnant, planning to become pregnant, or breastfeeding
• Initiated first antipsychotic treatment within the past 12 months
• Has received a long-acting injectable antipsychotic in the past 3 months
• Has participated in a clinical study involving any investigational product within the past 3 months, or is currently participating in a clinical study involving an investigational product.
• A positive urine drug test for drugs of abuse
• Additional criteria may apply