A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.

Inclusion criteria

• Diagnosis of chronic schizophrenia that is clinically stable
• Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
• Stable antipsychotic medication regimen for >/= 2 months before Screening
• Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study

Exclusion criteria

• Aripiprazole used within 30 days before Screening
• History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)
• Current diagnosis of an Axis I disorder other than schizophrenia
• History of seizure disorder or any condition associated with seizures
• History of neuroleptic malignant syndrome (NMS)
• Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies
• Received medication by IM injection within 30 days before Screening
• Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening
• DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening
• Donation of blood or blood components within 4 weeks before Screening