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

NCT ID: NCT00731549

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1081 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-11-30

Brief Summary

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

Detailed Description

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Active Treatment of aripiprazole IM depot (300mg or 400mg)

Group Type: EXPERIMENTAL

Aripiprazole IM Depot

Intervention Type: DRUG

300mg or 400mg

Interventions

Aripiprazole IM Depot

300mg or 400mg

Intervention Type: DRUG

Other Intervention Names

Oral Aripiprazole

Eligibility Criteria

Inclusion Criteria

• 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.
• Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
• Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
• # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
• Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

Exclusion Criteria

• Subjects 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. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
• Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
• Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
• Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
• Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
• Subjects with a history of hypersensitivity to antipsychotic agents.
• Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chandler, Arizona, United States

Anaheim, California, United States

Cerritos, California, United States

Chino, California, United States

Escondido, California, United States

Garden Grove, California, United States

Glendale, California, United States

Glendale, California, United States

Imperial, California, United States

La Habra, California, United States

Los Angeles, California, United States

National City, California, United States

Oceanside, California, United States

Orange, California, United States

Pasadena, California, United States

Pico Rivera, California, United States

San Bernardino, California, United States

San Diego, California, United States

San Diego, California, United States

Study Site

San Diego, California, United States

San Diego, California, United States

Sherman Oaks, California, United States

Torrance, California, United States

Highlands Ranch, Colorado, United States

Norwalk, Connecticut, United States

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

Bradenton, Florida, United States

Coral Springs, Florida, United States

Doral, Florida, United States

Gainesville, Florida, United States

Hollywood, Florida, United States

Kissimmee, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Orange City, Florida, United States

Orlando, Florida, United States

Plantation, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Hoffman Estates, Illinois, United States

Oak Brook, Illinois, United States

Indianapolis, Indiana, United States

Baton Rouge, Louisiana, United States

Baton Rouge, Louisiana, United States

Lake Charles, Louisiana, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Columbia, Maryland, United States

Flowood, Mississippi, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

St Louis, Missouri, United States

North Platte, Nebraska, United States

Albuquerque, New Mexico, United States

Buffalo, New York, United States

Buffalo, New York, United States

Cedarhurst, New York, United States

Holliswood, New York, United States

Jamaica, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Hickory, North Carolina, United States

Winston-Salem, North Carolina, United States

Canton, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Garfield Heights, Ohio, United States

Middleburg Heights, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Allentown, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Media, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Johnson City, Tennessee, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Austin, Texas, United States

Austin, Texas, United States

DeSoto, Texas, United States

Richmond, Virginia, United States

Bellevue, Washington, United States

Bothell, Washington, United States

Spokane, Washington, United States

Milwaukee, Wisconsin, United States

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Cordoba, Cordoba, , Argentina

La Plata, Buenos Aires, , Argentina

Mendoza, , Argentina

Dandenong, Victoria, Australia

Epping, Victoria, Australia

Frankston, Victoria, Australia

Fremantle, Western Australia, Australia

Glenside, SA, , Australia

Melbourne, , Australia

Innsbruck, , Austria

Bruges, , Belgium

Burgas, , Bulgaria

Lovech, , Bulgaria

Pazardzhik, , Bulgaria

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Radnevo, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Veliko Tarnovo, , Bulgaria

San Bernardo, Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Santiago, , Chile

Zagreb, , Croatia

Zagreb, , Croatia

Jämejala, , Estonia

Tallinn, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Helsinki, , Finland

Élancourt, , France

Rennes, , France

Saint-Nazaire, , France

Baja, , Hungary

Balassagyarmat, , Hungary

Cegléd, , Hungary

Győr, , Hungary

Ahmedabad, Gujarat, India

Bangalore, Karnataka, India

Chennai, Tamil Nadu, India

Kanpur, , India

Mangalore, , India

Pune, , India

Tirupati, , India

Kuala Lumpur, Kuala Lumpur, Malaysia

Kuala Lumpur, Kuala Lumpur, Malaysia

Tanjong Rambutan, Perak, Malaysia

Kuala Selangor, , Malaysia

Guadalajara, Jalisco, Mexico

Mexico City, Mexico City, Mexico

Monterrey, Nuevo León, Mexico

San Luis Potosí City, San Luis Potosí, Mexico

Culiacán, Sinaloa, Mexico

Ålesund, , Norway

Klepp stasjon, , Norway

Bataan, Central Luzon, Philippines

Mandaluyong, NCR, Philippines

Quezon City, NCR, Philippines

Iloilo City, Western Visayas, Philippines

Bełchatów, , Poland

Bialystok, , Poland

Bydgoszcz, , Poland

Choroszcz, , Poland

Krakow, , Poland

Leszno, , Poland

Pruszków, , 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

Košice, , Slovakia

Liptovský Mikuláš, , Slovakia

Prešov, , Slovakia

Rimavská Sobota, , Slovakia

Svidník, , Slovakia

Pretoria, Gauteng, South Africa

Cape Town, Western Province, South Africa

Busan, , South Korea

Deajeon, , South Korea

Gwangju, , South Korea

Joong-gu, Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Tainan City, , Taiwan

Taipei, , Taiwan

Muang, Chiangmai, Thailand

Muang, Chiangmai, Thailand

Bangkok, , Thailand

Countries

United States; Argentina; Australia; Austria; Belgium; Bulgaria; Chile; Croatia; Estonia; Finland; France; Hungary; India; Malaysia; Mexico; Norway; Philippines; Poland; Puerto Rico; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Taiwan; Thailand

Other Identifiers

31-08-248

Identifier Type: -

Identifier Source: org_study_id