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
Little Rock, Arkansas 72211
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Little Rock, AR
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Anaheim, California 92805
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Anaheim, CA
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Augusta, Georgia 30912
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Augusta, GA
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Chicago, Illinois 60611
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Chicago, IL
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Culver City, California 90230
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Culver City, CA
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Dallas, Texas 75231
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Dallas, TX
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Dallas, Texas 75231
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Dallas, TX
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Desoto, Texas 75115
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Desoto, TX
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Garden Grove, California 92845
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Garden Grove, CA
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Garfield Heights, Ohio 44125
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Garfield Heights, OH
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Lincoln, Rhode Island
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Lincoln, RI
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National City, California 91950
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National City, 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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Panorama City, California 91402
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Panorama City, CA
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Rogers, Arkansas 72758
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Rogers, AR
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Saint Louis, Missouri 63104
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Saint Louis, MO
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Shreveport, Louisiana 71101
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Shreveport, LA
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