A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia according to DSM-IV-TR criteria

• Has been able to achieve outpatient status for more than 3 months in the past year

• Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

• Resides in a stable living situation

• Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

• History of poor or inadequate clinical response to treatment with aripiprazole

• History of treatment resistance

• Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)

• Diagnosis of current substance dependence (including alcohol)

• Pregnant, lactating, or breastfeeding

• Receipt of any antipsychotic medication by IM injection within 60 days before Screening

• Current involuntary hospitalization or incarceration

• Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.