Hoyoung An1,2, Booyeol Choi3, Kun-Woo Park4, Do-Hoon Kim5, Dong-Won Yang6, Chang Hyung Hong7, Seong Yoon Kim3, Seol-Heui Han8. 1. National Institute of Dementia, Seongnam, South Korea. 2. Department of Psychiatry, Seoul National University Bundang Hospital, Seongnam, South Korea. 3. Department of Psychiatry, University of Ulsan College of Medicine Asan Medical Center, Seoul, South Korea. 4. Department of Neurology, Korea University, School of Medicine, Korea University Anam Hospital, Seoul, South Korea. 5. Department of Psychiatry, Hallym University, College of Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, South Korea. 6. Department of Neurology, The Catholic University of Korea, College of Medicine, Seoul St. Mary's Hospital, Seoul, South Korea. 7. Department of Psychiatry, Ajou University School of Medicine, Ajou University Medical Center, Suwon, South Korea. 8. Department of Neurology, Konkuk University College of Medicine, Konkuk University Medical Center, Seoul, South Korea.
Abstract
BACKGROUND: Effective treatments to alleviate depression in Alzheimer's disease (AD) have been scarce. OBJECTIVE: To investigate the efficacy and tolerability of escitalopram in the treatment of depression in AD. METHODS: In this 12-week randomized, double-blind, placebo-controlled trial with open-label, 12-week extension, AD subjects over 50 years of age, with depression defined by Olin's provisional diagnostic criteria, were enrolled. The Cornell Scale for Depression in Dementia (CSDD), and other measures of depression and cognition were repeated. RESULTS:91 subjects were screened, and 84 were randomized into either the study group or placebo group (n = 42 for both groups). Twenty-four subjects (29%) were unable to finish the study, yielding a per protocol population of 60 subjects (study group: n = 27; placebogroup: n = 33). At week 12, differences in measures of depression and cognition between the two groups were not statistically significant. However, exploratory analysis suggested that further research on a subset of subjects with 'definite major depression' (baseline CSDD score ≥18) is needed. The number of treatment-related adverse-events (AE) did not differ between groups (p = 0.83) and no serious treatment-related AE were observed. CONCLUSION: The use of escitalopram was well tolerated in depressive dementia patients. Future studies focusing on subjects with more severe levels of depression, and with more statistical power, will be needed.
RCT Entities:
BACKGROUND: Effective treatments to alleviate depression in Alzheimer's disease (AD) have been scarce. OBJECTIVE: To investigate the efficacy and tolerability of escitalopram in the treatment of depression in AD. METHODS: In this 12-week randomized, double-blind, placebo-controlled trial with open-label, 12-week extension, AD subjects over 50 years of age, with depression defined by Olin's provisional diagnostic criteria, were enrolled. The Cornell Scale for Depression in Dementia (CSDD), and other measures of depression and cognition were repeated. RESULTS: 91 subjects were screened, and 84 were randomized into either the study group or placebo group (n = 42 for both groups). Twenty-four subjects (29%) were unable to finish the study, yielding a per protocol population of 60 subjects (study group: n = 27; placebo group: n = 33). At week 12, differences in measures of depression and cognition between the two groups were not statistically significant. However, exploratory analysis suggested that further research on a subset of subjects with 'definite major depression' (baseline CSDD score ≥18) is needed. The number of treatment-related adverse-events (AE) did not differ between groups (p = 0.83) and no serious treatment-related AE were observed. CONCLUSION: The use of escitalopram was well tolerated in depressive dementiapatients. Future studies focusing on subjects with more severe levels of depression, and with more statistical power, will be needed.
Authors: Jennifer A Watt; Zahra Goodarzi; Areti Angeliki Veroniki; Vera Nincic; Paul A Khan; Marco Ghassemi; Yonda Lai; Victoria Treister; Yuan Thompson; Raphael Schneider; Andrea C Tricco; Sharon E Straus Journal: BMJ Date: 2021-03-24