title: Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep): A Pragmatic, Randomized, Non-Inferiority Trial.
abstract: OBJECTIVE
  ECT is the most effective treatment for severe depression. Previous efficacy studies, using thrice-weekly brief-pulse ECT, reported that high-dose (6× seizure threshold) right unilateral ECT is similar to bitemporal ECT but may have fewer cognitive side effects. The authors aimed to assess the effectiveness and cognitive side effects of twice-weekly moderate-dose (1.5× seizure threshold) bitemporal ECT with high-dose unilateral ECT in real-world practice.
  
  
  METHODS
  This was a pragmatic, patient- and rater-blinded, noninferiority trial of patients with major depression (N=138; 63% female; age=56.7 years [SD=14.8]) in a national ECT service with a 6-month follow-up. Participants were independently randomly assigned to bitemporal or high-dose unilateral ECT. The primary outcome was change in the 24-item Hamilton Depression Rating Scale (HAM-D) score after the ECT course; the prespecified noninferiority margin was 4.0 points. Secondary outcomes included response and remission rates, relapse status after 6 months, and cognition.
  
  
  RESULTS
  Of the eligible patients, 69 were assigned to bitemporal ECT and 69 to unilateral ECT. High-dose unilateral ECT was noninferior to bitemporal ECT regarding the 24-item HAM-D scores after the ECT course (mean difference=1.08 points in favor of unilateral ECT [95% CI=-1.67 to 3.84]). There were no significant differences for response and remission or 6-month relapse status. Recovery of orientation was quicker following unilateral ECT (median=19.1 minutes versus 26.4 minutes). Bitemporal ECT was associated with a lower percent recall of autobiographical information (odds ratio=0.66) that persisted for 6 months.
  
  
  CONCLUSIONS
  Twice-weekly high-dose unilateral ECT is not inferior to bitemporal ECT for depression and may be preferable because of its better cognitive side-effect profile.
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Maria
authors.initials: M
authors.lastname: Semkovska
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Sabine
authors.initials: S
authors.lastname: Landau
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Ross
authors.initials: R
authors.lastname: Dunne
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Erik
authors.initials: E
authors.lastname: Kolshus
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Adam
authors.initials: A
authors.lastname: Kavanagh
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Ana
authors.initials: A
authors.lastname: Jelovac
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Martha
authors.initials: M
authors.lastname: Noone
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Mary
authors.initials: M
authors.lastname: Carton
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Sinead
authors.initials: S
authors.lastname: Lambe
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Caroline
authors.initials: C
authors.lastname: McHugh
authors.affiliation: From the Department of Psychiatry, Trinity College Dublin, St. Patrick's University Hospital, Dublin, Ireland; Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland; the Department of Psychology, University of Limerick, Castletroy, Co. Limerick, Ireland; and the Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London.
authors.forename: Declan M
authors.initials: DM
authors.lastname: McLoughlin
mesh_terms: D000328:Adult; D000368:Aged; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D004565:Electroconvulsive Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008569:Memory Disorders / Q000209:etiology / Q000523:psychology*; D061212:Memory, Episodic; D008875:Middle Aged; D016896:Treatment Outcome