Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia



Status:Archived
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2008
End Date:January 2015

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A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia


To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as
maintenance treatment in patients with schizophrenia.


This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of
Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in
Studies 246/247. The treatment history of subjects prior to enrollment in the open-label
study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246
or 31-07-247).

This open-label study will be comprised of phases similar to the pivotal double-blind
studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase
(Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label
maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week
follow-up period.

During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will
be allowed for subjects who do not meet stability criteria or meet the criteria for
impending relapse/exacerbation of psychotic symptoms.


We found this trial at
28
sites
Austin, Texas
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Albany, New York
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Albany, NY
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Albuquerque, New Mexico
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Albuquerque, NM
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Atlanta, Georgia
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Atlanta, GA
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Celebration, Florida
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Celebration, FL
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Centralia, Illinois
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Centralia, IL
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Charleston, South Carolina
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Charleston, SC
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Charlotte, North Carolina
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Charlotte, NC
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Chevy Chase, Maryland 20815
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Denver, Colorado
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Denver, CO
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Jackson, Mississippi
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Jackson, MS
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Jeffersonville, Indiana
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Jeffersonville, IN
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Lima, OH
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Metairie, Louisiana
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Metairie, LA
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Milwaukee, Wisconsin
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Milwaukee, WI
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Nashville, Tennessee
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Newington, Connecticut
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Newington, CT
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Ogden, UT
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Omaha, Nebraska
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Peoria, Arizona
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Peoria, AZ
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Philadelphia, Pennsylvania
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Ponca City, Oklahoma
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Ponca City, OK
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Richmond, Virginia
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Santa Clara, California 95051
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St Louis, Missouri
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St Louis, MO
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Washington, District of Columbia
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Washington,
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