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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049021
Recruitment Status : Unknown
Verified January 2014 by Helio Elkis, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Helio Elkis, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Refractory Schizophrenia Super Refractory Schizophrenia Device: MECTA SPECTRUM 5000Q ECT Procedure: Sham ECT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049021


Contacts
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Contact: Helio Elkis, MD,PhD +55-1126617581 helkis@usp.br
Contact: Debora L Melzer-Ribeiro, MD +55-11999415282 deboramelzer@usp.br

Locations
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Brazil
Institute of Psychiatry - Clinics Hospital - University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403010
Contact: Helio Elkis, Md PhD    +55-11-2661-7322      
Contact: Debora Melzer, MD    +551126616525    deboramelzer@yahoo.com.br   
Principal Investigator: Helio Elkis, MD PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Hélio Elkis, MD PhD University of Sao Paulo

Additional Information:
Publications:

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Responsible Party: Helio Elkis, MD, PhD ; Associated Professor of the Departament of Psychiatric, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02049021    
Other Study ID Numbers: ECT Schizo
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Helio Elkis, University of Sao Paulo:
schizophrenia
electroconvulsive therapy
refractory Schizophrenia
super refractory schizophrenia
clozapine
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents