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

Use our guide to learn which trials are right for you!

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