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

Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia

Sponsors

Lead sponsor: University of Sao Paulo

Source 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.

Overall Status Unknown status
Start Date February 2010
Primary Completion Date January 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
PANSS change from baseline 4 weeks
PANSS change from baseline 2 weeks
Secondary Outcome
Measure Time Frame
CGI change from baseline 4 weeks
CGI change from baseline 2 weeks
Enrollment 20
Condition
Intervention

Intervention type: Device

Intervention name: MECTA SPECTRUM 5000Q ECT

Arm group label: Electroconvulsive Therapy

Intervention type: Procedure

Intervention name: Sham ECT

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

Arm group label: SHAM ECT

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Hélio Elkis, MD PhD Principal Investigator University of Sao Paulo
Overall Contact

Last name: Helio Elkis, MD,PhD

Phone: +55-1126617581

Email: [email protected]

Location
facility status contact contact_backup investigator Institute of Psychiatry - Clinics Hospital - University of Sao Paulo Helio Elkis, Md PhD +55-11-2661-7322 Helio Elkis, MD PhD Principal Investigator
Location Countries

Brazil

Verification Date

January 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Sao Paulo

Investigator full name: Helio Elkis

Investigator title: MD, PhD ; Associated Professor of the Departament of Psychiatric

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Electroconvulsive Therapy

Arm group type: Experimental

Description: Patients in use of clozapine randomized to receive ECT treatment

Arm group label: SHAM ECT

Arm group type: Sham Comparator

Description: Patients receiving clozapine randomized to sham ECT (placebo)

Acronym SSURECT
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov