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Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Refractory Schizophrenia; Super Refractory Schizophrenia

Intervention: MECTA SPECTRUM 5000Q ECT (Device); Sham ECT (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Hélio Elkis, MD PhD, Principal Investigator, Affiliation: University of Sao Paulo

Overall contact:
Helio Elkis, MD,PhD, Phone: +55-1126617581, Email: helkis@usp.br

Summary

Introduction: In spite of recent advances in schizophrenia treatment, 30% of patients still do not respond properly to antipsychotic therapy. These patients are considered treatment-resistant or refractory, and the best choice for them is clozapine. However, even supported by the literature as the best known antipsychotic in terms of efficacy and rates of response, a considerable number of patients will still not respond to this treatment, remaining symptomatic and dysfunctional. These patients are classified as super-refractory (clozapine-resistent). In these cases, augmenting strategies are necessary, and some have been in use: typical and atypical antipsychotics, mood stabilizers, antidepressants and electroconvulsive therapy (ECT). Some studies have favored ECT, but no definitive conclusion has been drawn. 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.

Clinical Details

Official title: Pilot Double Blind, Placebo Controlled and Randomized Study to Assess Electroconvulsive Therapy Efficacy as Augmenting Strategy to Clozapine in Super-refractory Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

PANSS change from baseline

PANSS change from baseline

Secondary outcome:

CGI change from baseline

CGI change from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR);

- 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:

- Clinical somatic disease not stabilized in the three months preceding the study;

- 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.

Locations and Contacts

Helio Elkis, MD,PhD, Phone: +55-1126617581, Email: helkis@usp.br

Institute of Psychiatry - Clinics Hospital - University of Sao Paulo, Sao Paulo 05403010, Brazil; Recruiting
Helio Elkis, Md PhD, Phone: +55-11-2661-7322
Debora Melzer, MD, Phone: +551126616525, Email: deboramelzer@yahoo.com.br
Helio Elkis, MD PhD, Principal Investigator
Additional Information

Institute of Psychiatry - University of Sao Paulo

Department of Psychiatry - University of Sao Paulo Medical School

Related publications:

Elkis H. Treatment-resistant schizophrenia. Psychiatr Clin North Am. 2007 Sep;30(3):511-33. Review.

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. Review.

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. 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. Review.

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. Review.

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.

Tharyan P, Adams CE. Electroconvulsive therapy for schizophrenia. Cochrane Database Syst Rev. 2002;(2):CD000076. Review. Update in: Cochrane Database Syst Rev. 2005;(2):CD000076.

Starting date: February 2010
Last updated: January 27, 2014

Page last updated: August 20, 2015

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