Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

Refractory Schizophrenia Clinical Trial

— SSURECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02049021
• Other study ID #: ECT Schizo
• Status: Recruiting
• Phase: Phase 4
• First received: January 15, 2014
• Last updated: January 27, 2014
• Start date: February 2010

Study information

• Verified date: January 2014
• Source: University of Sao Paulo
• Contact: Helio Elkis, MD,PhD
• Phone: +55-1126617581
• Email: helkis[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Comissão de Ética para Análise de Projetos de Pesquisa HCFMUSP - Ethichs Comitee - Clinics Hospital - University of São Paulo Medical SchoolBrazil: Ministerio da SaudeBrazil:Sistema Nacional de Informações Sobre Ética em Pesquisa envolvendo Seres Humanos (National Network in Research and Ethics applied to Human Beings)Brazil: National Committee of Ethics in ResearchBrazil: SISNEP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Refractory Schizophrenia
• Schizophrenia
• Super Refractory Schizophrenia

Intervention

Device:
• MECTA SPECTRUM 5000Q ECT

Procedure:
• Sham ECT
Sedation using propofol or etomidate and usual ECT preparation (no stimulation)

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry - Clinics Hospital - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS change from baseline	Structured assessments will be done at baseline, and at the end of the cycle of 12 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 4 weeks period.	4 weeks	No
Primary	PANSS change from baseline	Structured assessments will be done at baseline, and at the end of the cycle of 6 ECT sessions (thrice a week protocol). The assessments will be based on PANSS (Positive and Negative Syndrome Scale). Changes from Baseline on this scale will be documented after a 2 week period.	2 weeks	No
Secondary	CGI change from baseline	Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.	4 weeks	No
Secondary	CGI change from baseline	Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.	2 weeks	No

External Links

•   Department of Psychiatry - University of Sao Paulo Medical School
•   Institute of Psychiatry - University of Sao Paulo