Jeffery Newell1, Jerome A Yesavage2, Joy L Taylor3, Helena C Kraemer4, Cynthia A Munro5, Leah Friedman4, Paul B Rosenberg5, Michelle Madore3, Steven Z Chao6, D P Devanand7, Lea T Drye8, Jacobo E Mintzer9, Bruce G Pollock10, Anton P Porsteinsson11, Lon S Schneider12, David M Shade8, Daniel Weintraub13, Constantine G Lyketsos5, Art Noda4. 1. Department of Psychology, University of Southern California, Los Angeles, CA, 90089, United States. 2. Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, United States; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305-5717, United States; Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, 94305, United States. Electronic address: yesavage@stanford.edu. 3. Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, United States; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305-5717, United States. 4. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, 94305-5717, United States. 5. Department of Psychiatry and Behavioral Sciences, Johns Hopkins Bayview Medical Center and Johns Hopkins School of Medicine, Baltimore, MD, 21205, United States. 6. Department of Veterans Affairs Health Care System, Palo Alto, CA, 94304, United States; Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA, 94305, United States. 7. Division of Geriatric Psychiatry, New York State Psychiatric Institute, New York, NY, 10032, United States; College of Physicians and Surgeons of Columbia University, New York, NY, 10032, United States. 8. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, 21205, United States. 9. Clinical Biotechnology Research Institute, Roper St. Francis Healthcare, Charleston, SC, 29401, United States; Ralph H. Johnson VA Medical Center, SC, 29401, United States. 10. Campbell Institute, CAMH, University of Toronto, Toronto, Ontario, M5S 2S1, Canada. 11. University of Rochester School of Medicine and Dentistry, Rochester, NY, 14642, United States. 12. University of Southern California Keck School of Medicine, Los Angeles, CA, 90033, United States. 13. Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 19104, United States; Department of Veterans Affairs, Philadelphia, PA, 19104, United States.
Abstract
BACKGROUND: We found a benefit of citalopram for agitation in the Citalopram for Agitation in Alzheimer's Disease study (CitAD), and wondered if this was mediated by a sedative effect. CitAD was a randomized, placebo-controlled, double-blind, parallel group trial conducted at 8 academic centers in the United States and Canada from August 2009 to January 2013. One hundred sixty-two participants with probable Alzheimer's disease (AD) and clinically significant agitation were analyzed in this study. Participants received a psychosocial intervention and were randomized to receive either citalopram or placebo (approximately half assigned to each group). Participants were rated on the Neurobehavioral Rating Scale Agitation subscale and measures of sedation (i.e., fatigue and somnolence). METHODS: Using the MacArthur Foundation procedures for documenting a mediator effect, we performed a secondary analysis examining whether sedation mediates the effect of treatment on agitation outcome. RESULTS: We found a statistically significant mediating effect of sedation on agitation outcomes, but the magnitude of the effect was small, only explaining 11% of the variance in agitation, with a significant, but modest effect size of 0.16 (95% CI: 0.08 to 0.22). CONCLUSIONS: The benefit of citalopram was partly due to sedation but largely due to other mechanisms of action. Published by Elsevier Ltd.
RCT Entities:
BACKGROUND: We found a benefit of citalopram for agitation in the Citalopram for Agitation in Alzheimer's Disease study (CitAD), and wondered if this was mediated by a sedative effect. CitAD was a randomized, placebo-controlled, double-blind, parallel group trial conducted at 8 academic centers in the United States and Canada from August 2009 to January 2013. One hundred sixty-two participants with probable Alzheimer's disease (AD) and clinically significant agitation were analyzed in this study. Participants received a psychosocial intervention and were randomized to receive either citalopram or placebo (approximately half assigned to each group). Participants were rated on the Neurobehavioral Rating Scale Agitation subscale and measures of sedation (i.e., fatigue and somnolence). METHODS: Using the MacArthur Foundation procedures for documenting a mediator effect, we performed a secondary analysis examining whether sedation mediates the effect of treatment on agitation outcome. RESULTS: We found a statistically significant mediating effect of sedation on agitation outcomes, but the magnitude of the effect was small, only explaining 11% of the variance in agitation, with a significant, but modest effect size of 0.16 (95% CI: 0.08 to 0.22). CONCLUSIONS: The benefit of citalopram was partly due to sedation but largely due to other mechanisms of action. Published by Elsevier Ltd.
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