Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

NCT02049021 | Unknown Phase 4 DMC

• 1 other identifier: ECT Schizo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Schizophrenia; Super Refractory Schizophrenia

Keywords

schizophrenia; electroconvulsive therapy; refractory Schizophrenia; super refractory schizophrenia; clozapine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• CGI change from baseline

  4 weeks

• CGI change from baseline

  2 weeks

Study Arms (2)

Electroconvulsive Therapy

EXPERIMENTAL

Patients in use of clozapine randomized to receive ECT treatment

Device: MECTA SPECTRUM 5000Q ECT

SHAM ECT

SHAM COMPARATOR

Patients receiving clozapine randomized to sham ECT (placebo)

Procedure: Sham ECT

Interventions

MECTA SPECTRUM 5000Q ECT DEVICE

Also known as: ECT, Electrochock, electroconvulsive therapy device

Electroconvulsive Therapy

Sham ECT PROCEDURE

Sedation using propofol or etomidate and usual ECT preparation (no stimulation)

SHAM ECT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry - Clinics Hospital - University of Sao Paulo

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

Related Publications (7)

• Elkis H. Treatment-resistant schizophrenia. Psychiatr Clin North Am. 2007 Sep;30(3):511-33. doi: 10.1016/j.psc.2007.04.001.

  PMID: 17720034 BACKGROUND

• 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.

  PMID: 16518135 BACKGROUND

• 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.

  PMID: 15538604 BACKGROUND

• 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.

  PMID: 15000267 BACKGROUND

• 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.

  PMID: 15119912 BACKGROUND

• 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.

  PMID: 12691772 BACKGROUND

• Tharyan P, Adams CE. Electroconvulsive therapy for schizophrenia. Cochrane Database Syst Rev. 2002;(2):CD000076. doi: 10.1002/14651858.CD000076.

  PMID: 12076380 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hélio Elkis, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helio Elkis, MD,PhD

CONTACT

+55-1126617581; helkis@usp.br

Debora L Melzer-Ribeiro, MD

CONTACT

+55-11999415282; deboramelzer@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD ; Associated Professor of the Departament of Psychiatric

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 29, 2014
• Study Start: February 1, 2010
• Primary Completion: January 1, 2014
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

BR (1)