PMID- 26892939 OWN - NLM STAT- MEDLINE DCOM- 20160808 LR - 20180119 IS - 1535-7228 (Electronic) IS - 0002-953X (Linking) VI - 173 IP - 4 DP - 2016 Apr 1 TI - Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep): A Pragmatic, Randomized, Non-Inferiority Trial. PG - 408-17 LID - 10.1176/appi.ajp.2015.15030372 [doi] AB - OBJECTIVE: ECT is the most effective treatment for severe depression. Previous efficacy studies, using thrice-weekly brief-pulse ECT, reported that high-dose (6x 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 (1.5x seizure threshold) bitemporal ECT with high-dose unilateral ECT in real-world practice. METHOD: 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. FAU - Semkovska, Maria AU - Semkovska M AD - 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. FAU - Landau, Sabine AU - Landau S AD - 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. FAU - Dunne, Ross AU - Dunne R AD - 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. FAU - Kolshus, Erik AU - Kolshus E AD - 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. FAU - Kavanagh, Adam AU - Kavanagh A AD - 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. FAU - Jelovac, Ana AU - Jelovac A AD - 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. FAU - Noone, Martha AU - Noone M AD - 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. FAU - Carton, Mary AU - Carton M AD - 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. FAU - Lambe, Sinead AU - Lambe S AD - 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. FAU - McHugh, Caroline AU - McHugh C AD - 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. FAU - McLoughlin, Declan M AU - McLoughlin DM AD - 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. LA - eng SI - ISRCTN/ISRCTN23577151 PT - Comparative Study PT - Journal Article PT - Pragmatic Clinical Trial PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160219 PL - United States TA - Am J Psychiatry JT - The American journal of psychiatry JID - 0370512 SB - IM CIN - Am J Psychiatry. 2016 Jul 1;173(7):731. PMID: 27363553 CIN - Am J Psychiatry. 2016 Jul 1;173(7):731-2. PMID: 27363554 MH - Adult MH - Aged MH - Depressive Disorder, Major/psychology/*therapy MH - Electroconvulsive Therapy/adverse effects/*methods MH - Female MH - Humans MH - Male MH - Memory Disorders/etiology/*psychology MH - *Memory, Episodic MH - Middle Aged MH - Treatment Outcome EDAT- 2016/02/20 06:00 MHDA- 2016/08/09 06:00 CRDT- 2016/02/20 06:00 PHST- 2016/02/20 06:00 [entrez] PHST- 2016/02/20 06:00 [pubmed] PHST- 2016/08/09 06:00 [medline] AID - 10.1176/appi.ajp.2015.15030372 [doi] PST - ppublish SO - Am J Psychiatry. 2016 Apr 1;173(4):408-17. doi: 10.1176/appi.ajp.2015.15030372. Epub 2016 Feb 19.