An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia



Status:Active, not recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/22/2016
Start Date:June 2010
End Date:December 2018

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Purpose: To continue to provide aripiprazole intramuscular (IM) Depot treatment (400 mg or
300 mg) to subjects with schizophrenia completing the 52-week, open-label safety and
tolerability Study 31-08-248.

This is an open-label study which will enroll subjects with schizophrenia completing the
52-week, open-label safety and tolerability Study 31-08-248 and will continue to provide
aripiprazole intramuscular (IM) Depot treatment.

Subjects can receive this treatment until aripiprazole IM Depot is commercially available in
any dosage (including generic formulations) in the country that the study is being conducted
or the commercial availability of aripiprazole IM Depot is terminated by the sponsor, or
until the study end date of 31 Dec 2018 is reached.

Eligible subjects will enter this study at the End of Treatment visit (Week 52) of Study
248. Subjects will continue to receive aripiprazole IM Depot every month (study months are
every 4 weeks which is defined as 28 [-2/+10] days) as a continuation of their previous
monthly dose in Study 248.

Inclusion Criteria:

- Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria,
who completed the open-label extension Study 248 (completed Study 248 study
completion visit, Week 52).

- Subjects who, in the investigator's judgment, may benefit from continued
participation in an aripiprazole IM Depot study.

- The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the
first injection for Study 270 must occur within 4 weeks (which is defined as 28
[-2/+10] days) of the last injection in Study 248.

- Subjects who are able to provide written informed consent and/or consent obtained
from a legally acceptable representative (as require by IRB/IEC), prior to the
initiation of any protocol-required procedures.

- Subjects able to understand the nature of the study and follow protocol requirements
and who can read and understand the written word in order to complete
patient-reported outcomes measures.

- Outpatient status.

Exclusion Criteria:

- Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including
schizoaffective disorder, MDD, bipolar disorder, delirium, dementia, amnestic or
other cognitive disorders. Also, subjects with borderline, paranoid, histrionic,
schizotypal, schizoid or antisocial personality disorder.

- Subjects who currently meet DSM-IV-TR criteria for substance dependence; including
alcohol and benzodiazepines, but excluding caffeine and nicotine.

- Subjects with a significant risk of violent behavior or a significant risk of
committing suicide based on the investigator's judgment.

- Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
with aripiprazole or other quinolinones.

- Subjects with a history of neuroleptic malignant syndrome or clinically significant
tardive dyskinesia at screening.

- Electroconvulsive therapy within 180 days prior to entry.

- Any subject who requires or may need any other antipsychotic medications during the
course of the study.

- Aripiprazole IM Depot (including generic formulation) is commercially available in
the subject's country.

- Other protocol specific inclusion/exclusion criteria may apply
We found this trial at
52
sites
574
mi
from
Flowood, MS
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1209
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from
Allentown, PA
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1157
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from
Anaheim, CA
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801
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from
Atlanta, GA
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522
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from
Austin, TX
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4252
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from
Bellevue, CA
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1408
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from
Bothell, WA
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1056
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from
Buffalo, NY
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900
mi
from
Canton, OH
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Charleston, South Carolina 29412
1064
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from
Charleston, SC
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Charlotte, North Carolina 28207
959
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from
Charlotte, NC
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610
mi
from
Chicago, IL
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359
mi
from
Desoto, TX
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1127
mi
from
Escondido, CA
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1158
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from
Garden Grove, CA
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898
mi
from
Garfield Heights, OH
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1165
mi
from
Glendale, CA
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1314
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from
Hialeah, FL
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1323
mi
from
Homestead, FL
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1054
mi
from
Imperial, CA
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643
mi
from
Indianapolis, IN
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1297
mi
from
Jamaica, NY
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1228
mi
from
Jenkintown, PA
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5633
mi
from
La Plata,
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1168
mi
from
Los Angeles, CA
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1138
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from
Maitland, FL
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467
mi
from
Memphis, TN
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1315
mi
from
Miami Springs, FL
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630
mi
from
Milwaukee, WI
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National City, California 91950
1140
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from
National City, CA
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1290
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from
New York, NY
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280
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from
North Platte, NE
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1318
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from
Norwalk, CT
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594
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from
Oakbrook, IL
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1136
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from
Oceanside, CA
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158
mi
from
Oklahoma City, OK
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1154
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from
Orange, CA
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1128
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from
Orange City, FL
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1161
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from
Pasadena, CA
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1161
mi
from
Pico Rivera, CA
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1111
mi
from
Richmond, VA
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1122
mi
from
Rochester, NY
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San Bernardino, California 92408
1114
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from
San Bernardino, CA
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1143
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from
San Diego, CA
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Sellersville, Pennsylvania 18960
1217
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from
Sellersville, PA
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1178
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from
Sherman Oaks, CA
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429
mi
from
Shreveport, LA
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417
mi
from
St. Louis, MO
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1117
mi
from
Tampa, FL
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805
mi
from
Toledo, OH
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1178
mi
from
Torrance, CA
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1127
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from
Washington,
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