Randomized, double-blind, sham-controlled trial to evaluate the efficacy and tolerability of electroconvulsive therapy in patients with clozapine-resistant schizophrenia

Randomized, double-blind, sham-controlled trial to evaluate the efficacy and tolerability of electroconvulsive therapy in patients with clozapine-resistant schizophrenia

There is no established treatment for patients with clozapine-resistant schizophrenia (CRS). Clozapine augmentation strategies with antipsychotics or others substances are effective in comparison with placebo while and Electroconvulsive therapy (ECT) showed to be effective in comparison with treatme...

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Bibliographic Details
Published in:Schizophrenia research Vol. 268; pp. 252 - 260
Main Authors: Melzer-Ribeiro, D.L., Napolitano, I.C., Leite, S.A., Alencar de Souza, J.A., Vizzotto, A.D.B., Di Sarno, E.S., Fortes, M., Gomes, M.L., de Oliveira, G.M., Avrichir, B.S., Talib, L.L., Correll, C.U., Elkis, H.
Format: Journal Article
Language:English
Published: Netherlands Elsevier B.V 01-06-2024
Subjects:
Adult
Antipsychotic Agents - therapeutic use
CLOZAPINE
Clozapine - adverse effects
Clozapine - therapeutic use
Clozapine augmentation
Double-Blind Method
ECT
Electroconvulsive Therapy - adverse effects
Female
Humans
Male
Middle Aged
Outcome Assessment, Health Care
Psychiatric Status Rating Scales
Randomized-controlled trial
Schizophrenia - drug therapy
Schizophrenia - therapy
Schizophrenia, Treatment-Resistant - drug therapy
Schizophrenia, Treatment-Resistant - therapy
Sham-ECT
Treatment Outcome
Treatment resistance
CLOZAPINE
Treatment resistance
Randomized-controlled trial
Clozapine augmentation
ECT
Sham-ECT
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Summary:There is no established treatment for patients with clozapine-resistant schizophrenia (CRS). Clozapine augmentation strategies with antipsychotics or others substances are effective in comparison with placebo while and Electroconvulsive therapy (ECT) showed to be effective in comparison with treatment as usual (TAU) but not with placebo (sham-ECT). In the present double- blind randomized controlled trial, we compared 40 outpatients who received 20 sessions of ECT (n = 21) or sham-ECT (n = 19) (age = 37.40 ± 9.62, males = 77.5 %, illness duration = 14.95 ± 8.32 years, mean total Positive and Negative Syndrome Scale (PANSS) = 101.10 ± 24.91) who fulfilled well-defined CRS criteria including baseline clozapine plasma levels ≥350 ng/mL. The primary outcome was the ≥50 % PANSS Total Score reduction; secondary outcomes were the scores of the PANSS subscales, PANSS five-factor dimensions, PANSS-6 and the Calgary Depression Rating Scale (CDRS). Treatment response was analyzed by percentage reduction, Linear Mixed Models and effect sizes. At baseline both groups showed no differences except for years of school education (included as a covariate). At endpoint, only 1/19 of the completers (5.26 %) in the ECT group and 0/17 in the sham-ECT group showed a ≥50 % total PANSS score reduction. Both groups showed no significant differences of the total PANSS score (F = 0.12; p = 0.73), Positive (F = 0.27, p = 0.61), Negative (F = 0.25, p = 0.62), and General Psychopathology scores (F = 0.01, p = 0.94) as well for all PANSS five factors, the PANSS-6 and CDRS. Thus, the present study found no evidence that ECT is better than Sham-ECT in patients with CRS. Future sham-ECT controlled studies with larger sample sizes are warranted to test the efficacy of ECT for patients with CRS.
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ISSN:0920-9964
1573-2509
1573-2509
DOI:10.1016/j.schres.2023.11.009