Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia
NCT ID: NCT00328367
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
61 participants
INTERVENTIONAL
2005-12-31
2008-02-29
Brief Summary
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Detailed Description
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Comparisons: Design of double-blind randomized placebo controlled study of patients at Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National University Hospital.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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A
clozapine plus aripiprazole
aripiprazole
aripiprazole augmentation of clozapine
B
clozapine plus placebo
placebo
placebo
Interventions
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aripiprazole
aripiprazole augmentation of clozapine
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
* Patients must have a baseline (day 0) BPRS score of at least 35 or over 2 of 5 SANS global rating item scores of at least 3.
* Patients have been receiving clozapine treatment for more than 1 year and there has been no change in clozapine dosage for more than 3 months.
* Patients must have a history of antipsychotic treatment with at least 2 different kinds prior to clozapine administration.
* Subjects who are fluent in Korean.
Exclusion Criteria
* Female patients who are either pregnant or lactating.
* Mental retardation (IQ \< 70).
* Neurological disorders including epilepsy, stroke, or severe head trauma.
* Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
* Prior history of aripiprazole non-response or intolerance.
* BPRS score of \< 35 and over 4 of 5 SANS global rating item scores of \< 3.
* Participation in a clinical trial of another investigational drug within 3 months (90 days) prior to study entry.
* Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline (day 0).
* History of electroconvulsive therapy within the past 3 months.
* Subjects who are not fluent in Korean.
18 Years
65 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Principal Investigators
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Yong Sik Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Rocha FL, Hara C. Benefits of combining aripiprazole to clozapine: three case reports. Prog Neuropsychopharmacol Biol Psychiatry. 2006 Aug 30;30(6):1167-9. doi: 10.1016/j.pnpbp.2006.03.024. Epub 2006 May 2.
Henderson DC, Kunkel L, Nguyen DD, Borba CP, Daley TB, Louie PM, Freudenreich O, Cather C, Evins AE, Goff DC. An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia. Acta Psychiatr Scand. 2006 Feb;113(2):142-7. doi: 10.1111/j.1600-0447.2005.00612.x.
Ziegenbein M, Sieberer M, Calliess IT, Kropp S. Combination of clozapine and aripiprazole: a promising approach in treatment-resistant schizophrenia. Aust N Z J Psychiatry. 2005 Sep;39(9):840-1. doi: 10.1111/j.1440-1614.2005.01688_2.x. No abstract available.
Chang JS, Ahn YM, Park HJ, Lee KY, Kim SH, Kang UG, Kim YS. Aripiprazole augmentation in clozapine-treated patients with refractory schizophrenia: an 8-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008 May;69(5):720-31. doi: 10.4088/jcp.v69n0505.
Related Links
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Click here for detailed information about aripiprazole.
Other Identifiers
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KYS-2006-05209
Identifier Type: -
Identifier Source: org_study_id