Patient-Reported Outcomes From a Randomized Controlled Trial Comparing Right Unilateral Electroconvulsive Therapy With Algorithm-Based Pharmacological Treatment in Bipolar Depression, With Long-Term Follow-Up on Pharmacological Treatment
Abstract
Objective: The objective was to compare acute and long-term patient-reported outcome measures (PROMs) of symptoms and functioning in treatment-resistant bipolar depression following right unilateral (RUL) electroconvulsive therapy (ECT) and algorithm-based pharmacological treatment (APT).
Methods: Inpatients with treatment-resistant bipolar depression were randomized to 6 weeks of RUL ECT or APT, followed by pharmacological maintenance treatment for 6 months. Three PROMS-the Medical Outcome Short-Form Health Assessment (RAND-36), the Everyday Memory Questionnaire (EMQ-28), and the Patient Global Impression of Improvement (PGI-I)-and the clinician-rated Montgomery and Åsberg Depression Rating Scale (MADRS) were applied pretreatment, posttreatment, and 6 months posttreatment. Group comparisons were performed using linear mixed-effects analysis.
Results: Seventy-three patients (NRUL ECT = 38, NAPT = 35) were randomized to treatment, of which 44 (NRUL ECT = 23, NAPT = 21) completed acute treatment, and 39 (NRUL ECT = 20, NAPT = 19) completed the 6-month follow-up. Immediately posttreatment, RUL ECT and APT patients showed improvements in seven and three of the eight RAND-36 dimensions, respectively, while improvements on the PGI-I were greater for RUL ECT than for APT patients (2.2 vs. 2.9, p = 0.010) as were those on the MADRS (13.1 vs. 18.1, p = 0.010), with no group difference on the EMQ-28. At 6 months, there were no significant group differences for any measure. EMQ-28…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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