Dataset Information

Improved Safety of Hybrid Electroconvulsive Therapy Compared With Standard Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Parallel-Group Pilot Trial.

ABSTRACT:

Objectives

ECT is a rapid and effective treatment for depression. While efficacy is often remarkable over the initial 3-4 sessions, the efficacy of later sessions is less rapid, and the side-effects, especially cognitive impairment limit its use. To preliminarily compare the efficacy and acceptability of a novel hybrid-ECT (HECT) protocol for patients with major depressive disorder (MDD) with standard ECT, we conducted this pilot trial.

Methods

Thirty patients were randomly assigned to ECT or HECT. Both arms received three ECT sessions (phase 1) but, in phase 2, the HECT arm received low-charge electrotherapy instead of ECT. The primary outcome was the change in 24-item Hamilton depression rating scale (HAMD-24) scores between baseline and the end of treatment. Cognitive function was assessed by repeatable battery for the assessment of neuropsychological status (RBANS), Stroop color word, and orientation recovery tests (ORT). Safety was measured by the drop-out rate and adverse events (AEs). Four visits were conducted at baseline, post-phase 1, post-phase 2, and at 1-month follow-up. Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/), identifier: ChiCTR1900027701.

Results

Patients in both arms showed significant within-group improvements in HAMD-24, but the between-group differences were non-significant. Participants in the HECT arm outperformed ECT patients for most cognitive tests at the end of treatment or at follow-up. There was a significantly lower AE rate and shorter ORT in phase 2 of the HECT ar.

Conclusion

In this pilot trial, HECT was associated with fewer AEs and better cognitive function including executive and memory function, but its possible similar antidepressive efficacy needs to be further investigated in future.

SUBMITTER: Zhang JY

PROVIDER: S-EPMC9168000 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Improved Safety of Hybrid Electroconvulsive Therapy Compared With Standard Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Parallel-Group Pilot Trial.

Zhang Jing-Ya JY Xu Shu-Xian SX Zeng Lun L Chen Li-Chang LC Li Jia J Jiang Zhao-Yun ZY Tan Bai-Jian BJ Gu Chen-Long CL Lai Wen-Tao WT Kong Xiao-Ming XM Wang Jian J Rong Han H Xie Xin-Hui XH

Frontiers in psychiatry 20220523

<h4>Objectives</h4>ECT is a rapid and effective treatment for depression. While efficacy is often remarkable over the initial 3-4 sessions, the efficacy of later sessions is less rapid, and the side-effects, especially cognitive impairment limit its use. To preliminarily compare the efficacy and acceptability of a novel hybrid-ECT (HECT) protocol for patients with major depressive disorder (MDD) with standard ECT, we conducted this pilot trial.<h4>Methods</h4>Thirty patients were randomly assign ...[more]

PMID: 35677877

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Project description:ImportanceElectroconvulsive therapy (ECT) is indicated for severe depression, including depression with psychosis, catatonia, and/or an elevated suicide risk. However, the association of ECT with suicide risk is uncertain.ObjectiveTo determine the association between ECT and the risk of suicide in patients with unipolar major depressive disorder.Design, setting, and participantsThis registry-based cohort study used patient data from Swedish national registers. Patients with a record of inpatient care between January 1, 2012, and October 31, 2018, for moderate depression, severe depression, or severe depression with psychosis were included in the study. Propensity score matching (1:1) was used to balance risk factors for suicide at baseline between patients treated with and without ECT during the inpatient episode.ExposuresData from the Swedish National Quality Register for ECT and the Swedish National Inpatient Register were combined to identify patients who had received ECT during the inpatient episode. National registers were used to identify risk factors for suicide.Main outcomes and measuresSuicide within 3 and 12 months of admission to inpatient care was analyzed. Cox regression analyses were used to adjust for confounders.ResultsThe study included 28 557 patients (mean [SD] age, ECT group, 55.9 [18.4] years; non-ECT group, 45.2 [19.2] years; 15 856 women [55.5%]). In the matched sample of 5525 patients in each group, 62 patients (1.1%) in the ECT group and 90 patients (1.6%) in the non-ECT group died of suicide within 12 months (hazard ratio [HR], 0.72; 95% CI, 0.52-0.99). Electroconvulsive therapy was significantly associated with a decreased risk of suicide in patients with psychotic features (HR, 0.20; 95% CI, 0.08-0.54) and those aged 45 to 64 years (HR, 0.54; 95% CI, 0.30-0.99) or 65 years or older (HR, 0.30; 95% CI, 0.15-0.59), but not in patients aged 44 years or younger (HR, 1.22; 95% CI, 0.68-2.16).Conclusions and relevanceThe results of this cohort study support the continued use of ECT to reduce suicide risk in hospitalized patients who are severely depressed, especially those who are older than 45 years and those with a psychotic subtype.

Project description:ImportanceThe relative efficacy of ketamine and electroconvulsive therapy (ECT) in adults with major depressive episode (MDE) needs clarification.ObjectiveTo compare depression rating outcomes with ketamine vs ECT in adults with MDE and to compare response and remission rates, number of sessions to response and remission, and adverse effects.Data sourcesTwo investigators independently systematically searched MEDLINE, ScienceDirect, and Google Scholar databases using a combination of relevant Medical Subject Headings terms and free-text keywords from database inception through May 15, 2022, to identify relevant English-language trials.Study selectionParallel-group randomized clinical trials (RCTs).Data extraction and synthesisTwo investigators independently extracted data and assessed risk of bias. One-week posttreatment outcomes were pooled as standardized mean difference (SMD; Hedges g) for continuous outcomes and risk ratio (RR) for categorical outcomes in random-effects meta-analyses.Main outcomes and measuresEfficacy outcomes were 1-week (or nearest) posttreatment depression ratings, 1-week (or nearest) study-defined response and remission rates, and number of sessions to treatment response and remission. Safety outcomes were reported adverse effects.ResultsFive trials (ketamine group: n = 141; ECT group: n = 137) were meta-analyzed. The overall pooled SMD for posttreatment depression ratings was -0.39 (95% CI, -0.81 to 0.02; I2 = 45%; 5 RCTs). For this efficacy outcome, in a sensitivity analysis of methodologically stronger trials, ECT was superior to ketamine (SMD, -0.45; 95% CI, -0.75 to -0.14; I2 = 6%; 2 RCTs). ECT was also superior to ketamine for study-defined response (RR, 1.27; 95% CI, 1.06-1.53; I2 = 0%; 3 RCTs) and remission (RR, 1.43; 95% CI, 1.12-1.82; I2 = 0%; 2 RCTs) rates. No significant differences were noted between groups for number of sessions to response and remission and for cognitive outcomes. Key limitations were small number of studies, limited sample size, and high risk of bias in all trials.Conclusion and relevanceThe findings of this systematic review and meta-analysis suggest an efficacy advantage for ECT over ketamine in adults with MDE. These conclusions are tempered by the small number and size of existing trials.

Project description:ImportanceElectroconvulsive therapy (ECT) is highly effective and rapid in treating depression, but it carries a risk of significant cognitive adverse effects. Magnetic seizure therapy (MST), an investigational antidepressant treatment, may maintain the robust antidepressant efficacy of ECT while substantially reducing adverse effects due to its enhanced focality and weaker stimulation strength; however, previous clinical trials of MST were limited by small sample sizes.ObjectiveTo compare the antidepressant efficacy of MST vs ultrabrief pulse right unilateral (RUL) ECT.Design, setting, and participantsA between-participants, double-blinded, randomized clinical trial was conducted at 3 academic hospitals from June 2007 to August 2012. Adults aged 18 to 90 years who were referred for treatment with ECT, had a major depressive episode in the context of major depressive disorder or bipolar disorder, and had a baseline 24-item Hamilton Depression Rating Scale (HDRS-24) total score of 18 or higher were included. Participants were randomly assigned 1:1 to treatment with MST or ultrabrief pulse RUL ECT. After the treatment course, patients were naturalistically followed up for up to 6 months to examine the durability of clinical effects.InterventionsTreatment with MST, applied at 100 Hz at 100% of the maximum device power for 10 seconds, or ultrabrief pulse RUL ECT, applied at 6 times seizure threshold.Main outcomes and measuresThe primary outcome was change from baseline in HDRS-24 total score, with patients followed up for up to 6 months. A reduction of at least 50% in the HDRS-24 score indicated response, and at least a 60% decrease in the HDRS-24 score and a total score of 8 or less indicated remission.ResultsOf the 73 participants (41 [56.2%] female; mean [SD] age, 48 [14.1] years), 35 were randomized to MST and 38 to ECT. Among them, 53 (72.6%) were classified as completers (29 in the MST group and 24 in the ECT group). Both MST and ECT demonstrated clinically meaningful antidepressant effects. In the intent-to-treat sample, 18 participants (51.4%) in the MST group and 16 (42.1%) in the ECT group met response criteria; 13 (37.1%) in the MST group and 10 (26.3%) in the ECT group met remission criteria. Among completers, 17 of 29 (58.6%) in the MST group and 15 of 24 (62.5%) in the ECT group met response criteria; 13 of 29 (44.8%) in the MST group and 10 of 24 (41.7%) in the ECT group met remission criteria. There was no significant difference between MST and ECT for either response or remission rates. However, the mean (SD) number of treatments needed to achieve remission was 9.0 (3.1) with MST and 6.7 (3.3) with ECT, a difference of 2.3 treatments (t71.0 = 3.1; P = .003). Both MST and ECT showed a sustained benefit over a 6-month follow-up period, again with no significant difference between them. Compared with MST, ECT had significantly longer time to orientation after treatment (threshold level: F1,56 = 10.0; P = .003) and greater severity of subjective adverse effects, particularly in the physical and cognitive domains.Conclusions and relevanceThis randomized clinical trial found that the efficacy of MST was indistinguishable from that of ultrabrief pulse RUL ECT, the safest form of ECT currently available. These results support the continued development of MST and provide evidence for advantages relative to state-of-the-art ECT.Trial registrationClinicalTrials.gov Identifier: NCT00488748.

Dataset Information

Improved Safety of Hybrid Electroconvulsive Therapy Compared With Standard Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Parallel-Group Pilot Trial.

Objectives

Methods

Results

Conclusion

Publications

Improved Safety of Hybrid Electroconvulsive Therapy Compared With Standard Electroconvulsive Therapy in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Parallel-Group Pilot Trial.

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