Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
NCT ID: NCT00706654
Last Updated: 2013-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
937 participants
INTERVENTIONAL
2008-09-30
2012-08-31
Brief Summary
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The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Detailed Description
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During Phase 1 (oral conversion), subjects will be cross-titrated during weekly visits from other anti-psychotics to oral non-generic aripiprazole monotherapy over a minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (that will be a minimum of 8 weeks and a maximum of 28 weeks in duration), subjects will be assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria are met at Phase 2, subjects are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. Subjects will be randomized with a 2:2:1 (aripiprazole IM depot 300-400 mg monthly, oral aripiprazole 10-30 mg daily, aripiprazole IM depot 25-50 mg monthly). During Phase 3 subjects will be assessed for impending relapse/exacerbation of psychotic symptoms. If a subject is identified with impending relapse/exacerbation of psychotic symptoms, they will be withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549). Alternatively, any subject that discontinues in Phase 3 (up to and including Week 38) will have the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549).
The enrollment figure includes re-screened patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aripiprazole depot 300 or 400 mg
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Aripiprazole depot 300 or 400 mg
Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.
Placebo tablets
Placebo tablets were identical in appearance to the aripiprazole tablets.
Aripiprazole 10-30 mg orally
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Aripiprazole 10-30 mg orally
Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.
Placebo depot
Placebo depot was supplied in lyophilized vials.
Aripiprazole depot 25 or 50 mg
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Aripiprazole depot 25 or 50 mg
Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.
Placebo tablets
Placebo tablets were identical in appearance to the aripiprazole tablets.
Interventions
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Aripiprazole depot 300 or 400 mg
Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.
Aripiprazole 10-30 mg orally
Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.
Aripiprazole depot 25 or 50 mg
Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.
Placebo depot
Placebo depot was supplied in lyophilized vials.
Placebo tablets
Placebo tablets were identical in appearance to the aripiprazole tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
* Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, version 4, Text Revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening.
* Subjects who, in the investigator's judgment, require chronic treatment with an anti-psychotic 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 outcome measures, and who can be reliably rated on assessment scales.
Exclusion Criteria
* 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 2 positive drug screens for cocaine.
* Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents, including aripiprazole.
* Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
* Subjects with uncontrolled thyroid function abnormalities.
* Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments.
* Subjects who are involuntarily incarcerated.
* Subjects who have undergone electroconvulsive therapy within 180 days of entry into Phase 2.
* Subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole IM depot.
* Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results.
* Subjects hospitalized for more than 30 days in the 90 days prior to Phase 1 (or Phase 2 for subjects bypassing Phase 1).
* Subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam).
* Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors \[MAOI\]), and mood stabilizers, during screening and Phase 1.
18 Years
60 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Raymond Sanchez, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Cerritos, California, United States
Escondido, California, United States
Garden Grove, California, United States
Oceanside, California, United States
Orange, California, United States
Orange, California, United States
Pasadena, California, United States
Pico Rivera, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Torrance, California, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Kissimmee, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Shreveport, Louisiana, United States
Towson, Maryland, United States
Kansas City, Missouri, United States
Buffalo, 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
South Carolina, North Carolina, United States
Garfield Heights, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Richmond, Virginia, United States
Milwaukee, Wisconsin, United States
Innsbruck, , Austria
Bruges, , Belgium
Burgas, , Bulgaria
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Valdivia, , Chile
Zagreb, , Croatia
Zagreb, , Croatia
Jämejala, Viljandimaa, Estonia
Meegomäe, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Bully-les-Mines, , France
Élancourt, , France
Rennes, , France
Saint-Nazaire, , France
Baja, , Hungary
Balassagyarmat, , Hungary
Cegléd, , Hungary
Győőor, , Hungary
Milan, , Italy
Milan, , Italy
Pisa, , Italy
Bełchatów, , Poland
Bialystok, , Poland
Bydgoszcz, , Poland
Choroszcz, , Poland
Krakow, , Poland
Leszno, , Poland
Pruszków, , Poland
Sosnowiec, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Pretoria, Gauteng, South Africa
Cape Town, Western Province, South Africa
Busan, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Muang, Chiangmai, Thailand
Muang, Chiangmai, Thailand
Bangkok, , Thailand
Countries
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References
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Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. doi: 10.3371/CSRP.KASA.022015. Epub 2015 Feb 24.
Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.
Other Identifiers
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31-07-247
Identifier Type: -
Identifier Source: org_study_id