Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia (SSURECT)

January 27, 2014 updated by: Helio Elkis, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403010
        • Recruiting
        • Institute of Psychiatry - Clinics Hospital - University of Sao Paulo
        • Contact:
          • Helio Elkis, Md PhD
          • Phone Number: +55-11-2661-7322
        • Contact:
        • Principal Investigator:
          • Helio Elkis, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroconvulsive Therapy
Patients in use of clozapine randomized to receive ECT treatment
Device: MECTA SPECTRUM 5000Q ECT
Other Names:
  • ECT
  • Electrochock
  • electroconvulsive therapy device
Sham Comparator: SHAM ECT
Patients receiving clozapine randomized to sham ECT (placebo)
Procedure: Sham ECT
Sedation using propofol or etomidate and usual ECT preparation (no stimulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PANSS change from baseline
Time Frame: 4 weeks
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
Time Frame: 2 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGI change from baseline
Time Frame: 4 weeks
Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.
4 weeks
CGI change from baseline
Time Frame: 2 weeks
Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Hélio Elkis, MD PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 27, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT Schizo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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