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Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

NCT02049021 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-01-29

No results posted yet for this study

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

Interventions

DEVICE

MECTA SPECTRUM 5000Q ECT

PROCEDURE

Sham ECT

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

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Hélio Elkis, MD PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049021 on ClinicalTrials.gov