A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:12/6/2018
Start Date:December 2015
End Date:July 11, 2017

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Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection

This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as
ARISTADA, ALKS 9070).


Inclusion Criteria:

- Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR
has a history of tolerated use of aripiprazole

- Has a diagnosis of schizophrenia

- Is clinically stable

- Has received at least 3 doses of risperidone long acting injection (Risperdal Consta)
or paliperidone palmitate (Invega Sustenna) prior to screening.

- Has no antipsychotic medication regimen change for 4 weeks prior to Day 1

- Agreed to abide by the contraceptive requirements o the protocol

- Resides in a stable living situation

- Additional criteria may apply

Exclusion Criteria:

- Is currently pregnant or breastfeeding, or is planning to become pregnant during the
study

- Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6
months of screening

- Has participated in a clinical trial involving any investigational product within the
past 3 months, or is currently participating in a clinical trial involving an
investigational product

- Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine,
methadone, opiates, phencyclidine at screening

- Additional criteria may apply
We found this trial at
18
sites
Anaheim, California 92805
1960
mi
from 43215
Anaheim, CA
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Augusta, Georgia 30912
452
mi
from 43215
Augusta, GA
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Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
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Culver City, California 90230
1982
mi
from 43215
Culver City, CA
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Desoto, Texas 75115
922
mi
from 43215
Desoto, TX
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Garden Grove, California 92845
1967
mi
from 43215
Garden Grove, CA
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Garfield Heights, Ohio 44125
124
mi
from 43215
Garfield Heights, OH
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Lincoln, Rhode Island
618
mi
from 43215
Lincoln, RI
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Little Rock, Arkansas 72211
622
mi
from 43215
Little Rock, AR
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National City, California 91950
1949
mi
from 43215
National City, CA
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Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Orange, California 92868
1959
mi
from 43215
Orange, CA
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Panorama City, California 91402
1978
mi
from 43215
Panorama City, CA
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Rogers, Arkansas 72758
652
mi
from 43215
Rogers, AR
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Saint Louis, Missouri 63104
394
mi
from 43215
Saint Louis, MO
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Shreveport, Louisiana 71101
787
mi
from 43215
Shreveport, LA
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