Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia (SSURECT)
|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Primary Completion Date :||January 2014|
Experimental: Electroconvulsive Therapy
Patients in use of clozapine randomized to receive ECT treatment
Device: MECTA SPECTRUM 5000Q ECT
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)
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049021
|Contact: Helio Elkis, MD,PhDfirstname.lastname@example.org|
|Contact: Debora L Melzer-Ribeiro, MDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Helio Elkis, MD PhD|
|Principal Investigator:||Hélio Elkis, MD PhD||University of Sao Paulo|