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OBJECTIVE: The Montreal Cognitive Assessment (MoCA) is a commonly used brief cognitive screening tool for monitoring adverse cognitive effects of electroconvulsive therapy (ECT). The aim of this study was to examine three statistical methods for detecting reliable change in the MoCA following ECT. METHODS: In a prospective cohort study, 47 patients (mean age 55.2 [SD = 12.8], 59.6% female) with unipolar or bipolar depression treated with an acute course of brief-pulse ECT (72.3% right unilateral) and 47 depressed controls without ECT exposure were tested on the MoCA at baseline and retested at comparable time intervals. ECT patients' performance was also compared to published normative data from a community-based sample of older adults. We calculated proportions of ECT patients remaining stable, declining, and improving following ECT using practice-corrected reliable change index, standardized regression-based formulas, and minimum detectable change cutoff of ±4 MoCA points. RESULTS: Using the three methods, 72.3%-78.7% of ECT patients remained stable, 17.0%-23.4% declined, and 4.3% improved in MoCA performance following ECT compared to the two control groups. CONCLUSIONS: All three methods yield consistent estimates of reliable change in MoCA scores from pre- to post-brief-pulse ECT. The minimum detectable change approach may be the most efficient and accessible method of detecting change due to simplicity of calculation.
RESUMO
Background: Depression is a common psychiatric disorder that has become the leading cause of disability worldwide. The standard medical care for depression over the past 50 years has focused on monoamine neurotransmitters. These treatments can take weeks to take effect, highlighting the need for novel treatment strategies. One such approach may be ketamine. Ketamine acts as an antagonist of the N-methyl-D-asparate receptor and thus targets the excitatory amino acid neurotransmitter glutamate. Interestingly, at sub-anaesthetic doses, a single infusion of ketamine can elicit a rapid, though transient, antidepressant response. Methods: The aim of this study was to conduct a pragmatic randomised controlled pilot trial of four once-weekly ketamine infusions as an adjunctive therapy for depression. The main objective was to assess trial procedures to inform a future definitive trial. The primary clinical outcome was the 24-item Hamilton Rating Scale for Depression (HRSD-24). Trial participants were patients admitted to St Patrick's Mental Health Services for treatment of a depressive episode. They underwent usual inpatient care as prescribed by their treating team. Consented participants were randomly allocated to a four-week course of either once-weekly ketamine (0.5mg/kg) or midazolam (0.045mg/kg) infusions given over 40 minutes and with 12 weeks follow-up. Results: In total, 1581 admissions to St Patrick's Hospital were assessed for eligibility over nine months, with 125 (8%) meeting criteria, with 25 (20%) providing consent. In total, 13 were randomly assigned to the ketamine arm and 12 to the midazolam arm. There were no major differences in HRSD-24 scores between the two groups. The infusions were generally safe and well tolerated. Conclusions: This is the first pragmatic pilot trial of adjunctive serial ketamine infusions for hospitalised depression, an important possible use of ketamine. This study suggests that a definitive trial of adjunctive ketamine is feasible. Trial registration: ClinicalTrials.gov NCT03256162 21/08/2017; EudraCT 2016-004764-18 30/11/2016.
