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

• Status: Completed
• Trial end date: 2019-03-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Aripiprazole; Aripiprazole lauroxil; Paliperidone Palmitate

Criteria

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