Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
NCT ID: NCT01909466
Last Updated: 2015-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
141 participants
INTERVENTIONAL
2013-07-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gluteal Injection
Aripiprazole, OPC-14597
5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
Deltoid Injection
Aripiprazole, OPC-14597
5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
Interventions
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Aripiprazole, OPC-14597
5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
Eligibility Criteria
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Inclusion Criteria
* Prior history of tolerating aripiprazole per investigator's judgement.
Exclusion Criteria
* Subjects who use more than one antipsychotic medication at screening.
* Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
* Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
* Subjects currently in an acute relapse of schizophrenia.
* Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
* Subjects who are considered treatment-resistant to antipsychotic medications.
18 Years
64 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kimberly Largay, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Comprehensive Clinical Development
Cerritos, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
CNRI-San Diego
San Diego, California, United States
Comprehensive Clinical Development
Washington D.C., District of Columbia, United States
Scientific Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Compass Research North, LLC
Leesburg, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
CRI Lifetree
Marlton, New Jersey, United States
CRI Lifetree
Philadelphia, Pennsylvania, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Countries
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References
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Raoufinia A, Peters-Strickland T, Nylander AG, Baker RA, Eramo A, Jin N, Bricmont P, Repella J, McQuade RD, Hertel P, Larsen F. Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration. Int J Neuropsychopharmacol. 2017 Apr 1;20(4):295-304. doi: 10.1093/ijnp/pyw116.
Other Identifiers
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31-12-298
Identifier Type: -
Identifier Source: org_study_id
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