Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia
NCT ID: NCT02049021
Last Updated: 2014-01-29
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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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2010-02-28
Brief Summary
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Objective: Test the electroconvulsive therapy efficacy and safety as augmenting strategy to clozapine-resistant patients, as compared to placebo (sham ECT).
Methods: This is a pilot double blind, placebo controlled and randomized study to assess electroconvulsive therapy efficacy as augmenting strategy to clozapine in super-refractory schizophrenia. The ECT treatment will be delivered with either a MECTA SPECTRUM 5000Q or 4000Q device, and the procedure is under general anesthesia and monitorization, after informed consent. The Hospital will follow national protocols and regulations on ECT. Sham ECT consists in habitual patient preparation and sedation, without stimulation. Patients that fit inclusion criteria will have their clozapine blood levels dosed and undergo structured assessments at baseline, after 6 treatments and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on CGI (Clinical Global Impression) and PANSS (Positive and Negative Syndrome Scale) scales. All medication will be maintained, except lithium carbonate.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Electroconvulsive Therapy
Patients in use of clozapine randomized to receive ECT treatment
MECTA SPECTRUM 5000Q ECT
SHAM ECT
Patients receiving clozapine randomized to sham ECT (placebo)
Sham ECT
Sedation using propofol or etomidate and usual ECT preparation (no stimulation)
Interventions
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MECTA SPECTRUM 5000Q ECT
Sham ECT
Sedation using propofol or etomidate and usual ECT preparation (no stimulation)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages between 18 and 55 years old, both genders;
* Must be using adequate contraception if a fertile woman;
* Must be on clozapine treatment for at least 6 months, with or without augmenting strategies;
* Must be clozapine-resistent (super-refractory patient), defined by a CGI-severity ≥ 4, PANSS total score ≥ 60 and at least 4 items of the positive subscale ≥ 4 at baseline.
Exclusion Criteria
* Other Axis I disorders (DSM-IV-TR);
* Laboratory tests with significantly abnormal values that persist for more than two weeks;
* Lack of permanent residence during the study period;
* History of poor treatment adherence.
* History of ECT use in the past six months that precede the start of the study.
18 Years
55 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Helio Elkis
MD, PhD ; Associated Professor of the Departament of Psychiatric
Principal Investigators
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Hélio Elkis, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Institute of Psychiatry - Clinics Hospital - University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Helio Elkis, Md PhD
Role: primary
References
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Elkis H. Treatment-resistant schizophrenia. Psychiatr Clin North Am. 2007 Sep;30(3):511-33. doi: 10.1016/j.psc.2007.04.001.
Havaki-Kontaxaki BJ, Ferentinos PP, Kontaxakis VP, Paplos KG, Soldatos CR. Concurrent administration of clozapine and electroconvulsive therapy in clozapine-resistant schizophrenia. Clin Neuropharmacol. 2006 Jan-Feb;29(1):52-6. doi: 10.1097/00002826-200601000-00012.
Kho KH, Blansjaar BA, de Vries S, Babuskova D, Zwinderman AH, Linszen DH. Electroconvulsive therapy for the treatment of clozapine nonresponders suffering from schizophrenia--an open label study. Eur Arch Psychiatry Clin Neurosci. 2004 Dec;254(6):372-9. doi: 10.1007/s00406-004-0517-y. Epub 2004 Nov 12.
Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. No abstract available.
Miller A, Hall CS, Buchanan RW, Buckley PF, Chiles JA, Conley RR, Crismon ML, Ereshefsky L, Essock SM, Finnerty M, Marder SR, Miller DD, McEvoy JP, Rush AJ, Saeed SA, Schooler NR, Shon SP, Stroup S, Tarin-Godoy B. The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2003 update. J Clin Psychiatry. 2004 Apr;65(4):500-8. doi: 10.4088/jcp.v65n0408.
Tang WK, Ungvari GS. Efficacy of electroconvulsive therapy in treatment-resistant schizophrenia: a prospective open trial. Prog Neuropsychopharmacol Biol Psychiatry. 2003 May;27(3):373-9. doi: 10.1016/S0278-5846(02)00354-8.
Tharyan P, Adams CE. Electroconvulsive therapy for schizophrenia. Cochrane Database Syst Rev. 2002;(2):CD000076. doi: 10.1002/14651858.CD000076.
Related Links
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Institute of Psychiatry - University of Sao Paulo
Department of Psychiatry - University of Sao Paulo Medical School
Other Identifiers
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ECT Schizo
Identifier Type: -
Identifier Source: org_study_id
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