Trial record 3 of 589 for:    Open Studies | "Schizophrenia"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Helio Elkis, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02049021
First received: January 15, 2014
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Refractory Schizophrenia
Super Refractory Schizophrenia
Device: MECTA SPECTRUM 5000Q ECT
Procedure: Sham ECT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • PANSS change from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • PANSS change from baseline [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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:
  • CGI change from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.

  • CGI change from baseline [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression will be assessed as well, along with PANSS scale, and changes compared to baseline.


Estimated Enrollment: 20
Study Start Date: February 2010
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049021

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

Locations
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
Principal Investigator: Hélio Elkis, MD PhD University of Sao Paulo
  More Information

Additional Information:
Publications:

Responsible Party: Helio Elkis, MD, PhD ; Associated Professor of the Departament of Psychiatric, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02049021     History of Changes
Other Study ID Numbers: ECT Schizo
Study First Received: January 15, 2014
Last Updated: January 27, 2014
Health Authority: Brazil: Comissão de Ética para Análise de Projetos de Pesquisa HCFMUSP - Ethichs Comitee - Clinics Hospital - University of São Paulo Medical School
Brazil: Ministerio da Saude
Brazil:Sistema Nacional de Informações Sobre Ética em Pesquisa envolvendo Seres Humanos (National Network in Research and Ethics applied to Human Beings)
Brazil: National Committee of Ethics in Research
Brazil: SISNEP

Keywords provided by University of Sao Paulo:
schizophrenia
electroconvulsive therapy
refractory Schizophrenia
super refractory schizophrenia
clozapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on July 23, 2014