An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia
NCT ID: NCT01129882
Last Updated: 2020-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2010-06-24
2018-12-06
Brief Summary
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Detailed Description
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Participants received this treatment until aripiprazole IM Depot was commercially available in any dosage (including generic formulations) in the country where the study was being conducted or the commercial availability of aripiprazole IM Depot was terminated by the sponsor, or until the study completion date of 06 Dec 2018 was reached.
Eligible participants entered this study at the end of treatment visit (Week 52) of Study 31-08-248. Participants continued to receive aripiprazole IM depot every month (study months were every 4 weeks, which were defined as 28 \[-2/+10\] days) as a continuation of their previous monthly dose in Study 31-08-248.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aripiprazole IM depot
Active treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)
Aripiprazole
Aripiprazole IM depot - 300 mg or 400 mg
Interventions
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Aripiprazole
Aripiprazole IM depot - 300 mg or 400 mg
Eligibility Criteria
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Inclusion Criteria
* Participants 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 was defined as 28 \[-2/+10\] days) of the last injection in Study 248.
* Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.
* Participants 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
* Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
* Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.
* Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
* Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
* Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
* Electroconvulsive therapy within 180 days prior to entry.
* Any participant 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 participant's country.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Bellevue, California, United States
Garden Grove, California, United States
Glendale, California, United States
Glendale, California, United States
Imperial, California, United States
Los Angeles, California, United States
National City, California, United States
National City, California, United States
Orange, California, United States
Pasadena, California, United States
Pico Rivera, California, United States
Pico Rivera, California, United States
San Bernardino, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Orange City, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Flowood, Mississippi, United States
St Louis, Missouri, United States
North Platte, Nebraska, United States
Buffalo, New York, United States
New York, New York, United States
Queens, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Akron, Ohio, United States
Canton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Jenkintown, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
DeSoto, Texas, United States
Richmond, Virginia, United States
Bothell, Washington, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mendoza, , Argentina
Epping, Victoria, Australia
Frankston, Victoria, Australia
Fremantle, Western Australia, Australia
Burgas, , Bulgaria
Lovech, , Bulgaria
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Radnevo, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Tserova Koria, , Bulgaria
Varna, , Bulgaria
Varna, , Bulgaria
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Valdivia, , Chile
Zagreb, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Viljandi, , Estonia
Helsinki, , Finland
Baja, , Hungary
Balassagyarmat, , Hungary
Gyõr, , Hungary
Ahmedabad, Gujarat, India
Mangalore, Karnataka, India
Bangalore, , India
Chennai, , India
Kanpur, , India
Pune, , India
Tirupati, , India
Ipoh, , Malaysia
Kajang, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Culiacán, Sinaloa, Mexico
México, , Mexico
San Luis Potosí City, , Mexico
Mandaluyong, NCR, Philippines
Iloilo City, Western Visayas, Philippines
Mariveles, , Philippines
Bełchatów, , Poland
Bialystok, , Poland
Bydgoszcz, , Poland
Choroszcz, , Poland
Krakow, , Poland
Leszno, , Poland
Sosnowiec, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Arad, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Oradea, , Romania
Piteşti, , Romania
Lipetsk, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Bardejov, , Slovakia
Košice, , Slovakia
Liptovský Mikuláš, , Slovakia
Prešov, , Slovakia
Rimavská Sobota, , Slovakia
Cape Town, Western Province, South Africa
Bellville, , South Africa
Pretoria West, , South Africa
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
L'Hospitalet de Llobregat, , Spain
Tainan City, , Taiwan
Taipei, , Taiwan
Chiang Mai, , Thailand
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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31-10-270
Identifier Type: -
Identifier Source: org_study_id
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