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

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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 (N RUL ECT = 38, N APT = 35) were randomized to treatment, of which 44 (N RUL ECT = 23, N APT = 21) completed acute treatment, and 39 (N RUL ECT = 20, N APT = 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 scores improved significantly from pretreatment to the 6‐month follow‐up only in the RUL ECT group (122.5 vs. 91.6, p < 0.001). Conclusion: Two PROMs and the clinician‐rated MADRS favored RUL ECT over APT after 6 weeks of treatment. These findings show the acute benefit of RUL ECT in the treatment of bipolar depression.

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