Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial

Abstract

We examined whether electroconvulsive therapy (ECT) plus medications ("STABLE + PHARM" group) had superior HRQOL compared with medications alone ("PHARM" group) as continuation strategy after successful acute right unilateral ECT for major depressive disorder (MDD). We hypothesized that scores from the Medical Outcomes Study Short Form-36 (SF-36) would be higher during continuation treatment in the "STABLE + PHARM" group versus the "PHARM" group. The overall study design was called "Prolonging Remission in Depressed Elderly" (PRIDE). Remitters to the acute course of ECT were re-consented to enter a 6 month RCT of "STABLE + PHARM" versus "PHARM". Measures of depressive symptoms and cognitive function were completed by blind raters; SF-36 measurements were patient self-report every 4 weeks. Participants were 120 patients >60 years old. Patients with dementia, schizophrenia, bipolar disorder, or substance abuse were excluded. The "PHARM" group received venlafaxine and lithium. The "STABLE + PHARM" received the same medications, plus 4 weekly outpatient ECT sessions, with additional ECT session as needed. Participants were mostly female (61.7%) with a mean age of 70.5 ± 7.2 years. "STABLE + PHARM" patients received 4.5 ± 2.5 ECT sessions during Phase 2. "STABLE + PHARM" group had 7 point advantage (3.5-10.4, 95% CI) for Physical Component Score of SF-36 (P < 0.0001), and 8.2 point advantage (4.2-12.2, 95% CI) for Mental Component Score (P < 0.0001). Additional ECT resulted in overall net health benefit. Consideration should be given to administration of additional ECT to prevent relapse during the continuation phase of treatment of MDD. CLINICAL TRIALS.GOV: NCT01028508.

Keywords: Continuation therapy; Electroconvulsive therapy; Major depressive disorder; Quality of life; Randomized controlled trial.

Conflict of interest statement

Conflict of Interest

Dr. McCall has been a scientific advisor for Merck, and Israeli Growth Partners, and a consultant to Luitpold Pharmaceuticals, Inc and Multiple Energy Technologies, LLC. Dr. Kellner receives honoraria from UpToDate, Psychiatric Times, and Northshore-LIJ Health System, and is a consultant to Luitpold Pharmaceuticals, Inc. Dr. Husain has received grant support from NIDA, NINDS, NIA, NARSD, Stanley Foundation, Cyberonics, Neuronetics, St. Jude medical (ANS), MagStim, Brainsway, NeoSync, Avanir, Alkermes, and has been a consultant to the Neurological Devices Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health, Food and Drug Administration (FDA). Dr. Young is a consultant to the NIH. Dr. Lisanby has received grant support from NINDS, NIBIB, Brain and Behavior Research Foundation, Stanley Medical Research Foundation, Neosync, Nexstim, and Brainsway. Dr. Petrides has received research support from Amgen, Astra Zeneca, Corcept, Eli Lilly, Proteus, St. Jude Medical, and Sunovion, and he has served on an advisory panel for Corcept. Dr. McClintock has received grant support from the NIH/NIMH, honoraria from TMS Health Solutions and the US Department of Veteran Affairs, and is a consultant to Pearson. Dr. Nagy Youssef received grant support from the Department of Veterans Affairs, and CME honoraria form the Georgia Department of Behavioral Health and Developmental Disabilities. The other authors report no financial relationships with commercial interests.

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