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 |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/1/2019 |
Start Date: | December 2011 |
End Date: | March 2014 |
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
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.
ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
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.
We found this trial at
24
sites
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