A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
Sponsored by Alkermes, Inc.
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 11 years ago
What is this trial about?
What are the participation requirements?
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.