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
Dallas, Texas 75231
341
mi
from
Dallas, TX
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Atlanta, Georgia 30308
801
mi
from
Atlanta, GA
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Austin, Texas 78731
517
mi
from
Austin, TX
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5913
mi
from
Burgas,
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Cerritos, California 90703
1162
mi
from
Cerritos, CA
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Charleston, South Carolina 29407
1063
mi
from
Charleston, SC
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Chicago, Illinois 60611
610
mi
from
Chicago, IL
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Creve Coeur, Missouri 63141
406
mi
from
Creve Coeur, MO
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Fort Lauderdale, Florida 33308
1306
mi
from
Fort Lauderdale, FL
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Garden Grove, California 92845
1162
mi
from
Garden Grove, CA
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Hoffman Estates, Illinois 60169
593
mi
from
Hoffman Estates, IL
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La Habra, California 90631
1155
mi
from
La Habra, CA
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Leesburg, Florida 34748
1106
mi
from
Leesburg, FL
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Little Rock, Arkansas 72211
372
mi
from
Little Rock, AR
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Oakland, California 94612
1331
mi
from
Oakland, CA
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Oceanside, California 92056
1138
mi
from
Oceanside, CA
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Orange, California 92868
1154
mi
from
Orange, CA
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Overland Park, Kansas 66212
190
mi
from
Overland Park, KS
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Philadelphia, Pennsylvania 19131
1225
mi
from
Philadelphia, PA
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Rockville, Maryland 20850
1120
mi
from
Rockville, MD
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Saint Louis, Missouri 63104
418
mi
from
Saint Louis, MO
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San Diego, California 92123
1138
mi
from
San Diego, CA
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Springdale, Arkansas 72764
230
mi
from
Springdale, AR
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Washington, District of Columbia 20016
1127
mi
from
Washington,
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