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
Shreveport, Louisiana 71101
1410
mi
from 02139
Shreveport, LA
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Anaheim, California 92805
2578
mi
from 02139
Anaheim, CA
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Augusta, Georgia 30912
852
mi
from 02139
Augusta, GA
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Chicago, Illinois 60611
846
mi
from 02139
Chicago, IL
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Culver City, California 90230
2598
mi
from 02139
Culver City, CA
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Dallas, Texas 75231
1541
mi
from 02139
Dallas, TX
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Dallas, Texas 75231
1541
mi
from 02139
Dallas, TX
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Desoto, Texas 75115
1556
mi
from 02139
Desoto, TX
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Garden Grove, California 92845
2585
mi
from 02139
Garden Grove, CA
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Garfield Heights, Ohio 44125
543
mi
from 02139
Garfield Heights, OH
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Lincoln, Rhode Island
35
mi
from 02139
Lincoln, RI
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Little Rock, Arkansas 72211
1254
mi
from 02139
Little Rock, AR
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National City, California 91950
2574
mi
from 02139
National City, CA
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Oceanside, California 92056
2567
mi
from 02139
Oceanside, CA
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Orange, California 92868
2578
mi
from 02139
Orange, CA
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Panorama City, California 91402
2593
mi
from 02139
Panorama City, CA
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Rogers, Arkansas 72758
1293
mi
from 02139
Rogers, AR
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Saint Louis, Missouri 63104
1033
mi
from 02139
Saint Louis, MO
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