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

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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.


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
Atlanta, Georgia 30308
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Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Burgas,
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Cerritos, California 90703
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Cerritos, CA
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Charleston, South Carolina 29407
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Charleston, SC
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Chicago, Illinois 60611
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Chicago, IL
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Creve Coeur, Missouri 63141
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Creve Coeur, MO
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Dallas, Texas 75231
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Dallas, TX
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Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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Garden Grove, California 92845
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Garden Grove, CA
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Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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La Habra, California 90631
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La Habra, CA
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Leesburg, Florida 34748
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Leesburg, FL
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Little Rock, Arkansas 72211
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Little Rock, AR
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Oakland, California 94612
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Oakland, CA
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Oceanside, California 92056
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Oceanside, CA
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Orange, California 92868
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Orange, CA
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Overland Park, Kansas 66212
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Overland Park, KS
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Philadelphia, Pennsylvania 19131
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Philadelphia, PA
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Rockville, Maryland 20850
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Rockville, MD
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Saint Louis, Missouri 63104
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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Springdale, Arkansas 72764
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Springdale, AR
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Washington, District of Columbia 20016
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Washington,
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