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

NCT01129882 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 31-10-270
• Study Type: interventional
• Target: 709
• Locations: 23 countries
• Sites: 154

Brief Summary

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams \[mg\] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)

  A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

  Baseline to Month 97 (+/- 3 days)

Secondary Outcomes (1)

• Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit

  Baseline, Month 91

Study Arms (1)

Aripiprazole IM depot

EXPERIMENTAL

Active treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Aripiprazole IM depot - 300 mg or 400 mg

Aripiprazole IM depot

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
• 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.

You may not qualify if:

• Participants with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders.
• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (157)

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Bellevue, California, 98007, United States

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Garden Grove, California, 92845, United States

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Glendale, California, 91204, United States

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Glendale, California, 91206, United States

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Imperial, California, 92251, United States

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Los Angeles, California, 90024, United States

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National City, California, 91950, United States

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National City, California, United States

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Orange, California, 92868, United States

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Pasadena, California, 91107, United States

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Pico Rivera, California, 90660, United States

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Pico Rivera, California, United States

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San Bernardino, California, 92408-3304, United States

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San Diego, California, United States

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Sherman Oaks, California, 91403, United States

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Norwalk, Connecticut, 06851, United States

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Washington D.C., District of Columbia, 20016, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Doral, Florida, United States

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Hialeah, Florida, 33016, United States

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Homestead, Florida, 33030, United States

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Orange City, Florida, 32763, United States

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Tampa, Florida, 33613, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60640, United States

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Oak Brook, Illinois, 60523, United States

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Indianapolis, Indiana, 46222, United States

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Shreveport, Louisiana, 71101, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63109, United States

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North Platte, Nebraska, 69101, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10035, United States

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Queens, New York, United States

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Rochester, New York, 14615, United States

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Charlotte, North Carolina, 28204, United States

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Akron, Ohio, United States

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Canton, Ohio, 44718, United States

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Toledo, Ohio, 43609, United States

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Oklahoma City, Oklahoma, 73112, United States

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Allentown, Pennsylvania, 18104, United States

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Jenkintown, Pennsylvania, 19046, United States

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Sellersville, Pennsylvania, 18960, United States

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Charleston, South Carolina, 29401, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78754, United States

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DeSoto, Texas, 75115, United States

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Richmond, Virginia, 23230, United States

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Bothell, Washington, 98011, United States

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Milwaukee, Wisconsin, 53226, United States

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Buenos Aires, 1900, Argentina

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Buenos Aires, C1058AAH, Argentina

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Buenos Aires, C1405BOA, Argentina

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Buenos Aires, C1425AHQ, Argentina

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Mendoza, M5500HYF, Argentina

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Epping, Victoria, 3076, Australia

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Frankston, Victoria, 3199, Australia

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Fremantle, Western Australia, 6959, Australia

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Burgas, 8000, Bulgaria

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Lovech, 5500, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Plovdiv, Bulgaria

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Radnevo, 6260, Bulgaria

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Rousse, 7003, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1632, Bulgaria

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Tserova Koria, Bulgaria

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Varna, 9001, Bulgaria

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Varna, Bulgaria

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Santiago, 7500710, Chile

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Santiago, 7510186, Chile

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Santiago, 7580307, Chile

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Santiago, 8330838, Chile

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Santiago, 8780000, Chile

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Santiago, 8900085, Chile

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Temuco, 4781151, Chile

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Valdivia, 5090145, Chile

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Zagreb, 10000, Croatia

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Zagreb, 10090, Croatia

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Zagreb, Croatia

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Tallinn, 10614, Estonia

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Tallinn, 10617, Estonia

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Tartu, 50417, Estonia

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Tartu, Estonia

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Viljandi, 71024, Estonia

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Helsinki, 250, Finland

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Baja, 6500, Hungary

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Balassagyarmat, 2660, Hungary

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Gyõr, 9023, Hungary

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Ahmedabad, Gujarat, 380006, India

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Mangalore, Karnataka, 575018, India

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Bangalore, India

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Chennai, India

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Kanpur, 208005, India

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Pune, 411004, India

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Tirupati, 517507, India

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Ipoh, Malaysia

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Kajang, Malaysia

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Kuala Lumpur, 56000, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Guadalajara, Jalisco, 44280, Mexico

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Monterrey, Nuevo León, 64040, Mexico

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Culiacán, Sinaloa, 80020, Mexico

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México, 7760, Mexico

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San Luis Potosí City, 78218, Mexico

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Mandaluyong, NCR, 1553, Philippines

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Iloilo City, Western Visayas, 5000, Philippines

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Mariveles, Philippines

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Bełchatów, 97-400, Poland

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Bialystok, 15-879, Poland

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Bydgoszcz, 85096, Poland

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Choroszcz, 16-070, Poland

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Krakow, 31-501, Poland

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Leszno, 64-100, Poland

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Sosnowiec, 41-200, Poland

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Wroclaw, 50-227, Poland

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San Juan, 00918, Puerto Rico

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Arad, 310022, Romania

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Bucharest, 41914, Romania

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Cluj-Napoca, 400012, Romania

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Craiova, 200620, Romania

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Oradea, 410163, Romania

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Piteşti, 110069, Romania

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Lipetsk, 398007, Russia

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Moscow, 115522, Russia

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Moscow, 127083, Russia

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Nizhny Novgorod, 603152, Russia

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Nizhny Novgorod, 603155, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Bardejov, Slovakia

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Košice, 041 90, Slovakia

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Liptovský Mikuláš, 3101, Slovakia

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Prešov, Slovakia

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Rimavská Sobota, Slovakia

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Cape Town, Western Province, 7530, South Africa

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Bellville, 7530, South Africa

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Pretoria West, 1, South Africa

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Daejeon, 301-721, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 400-711, South Korea

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Seoul, 110-744, South Korea

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Barcelona, 08006, Spain

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Barcelona, 8036, Spain

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L'Hospitalet de Llobregat, Spain

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Tainan, 704, Taiwan

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Taipei, 110, Taiwan

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Chiang Mai, Thailand

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MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2010
• First Posted: May 25, 2010
• Study Start: June 24, 2010
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

RU (9); AR (5); CR (3); HU (3); ME (5); CL (8); ZA (3); ES (5); SL (5); IN (7); SE (2); PH (3); BU (14); RO (6); TW (2); AU (3); PL (8); MY (4); KR (4); FI (1); US (52); TH (1); PR (1)