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 baselinePANSS change from baseline
Secondary outcome: CGI change from baselineCGI 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
|