Change in agitation in Alzheimer's disease in the placebo arm of a nine-week controlled trial
| Autor: | Jeffery Newell, Paul B. Rosenberg, Jacobo Mintzer, Christopher Marano, Daniel Weintraub, Constantine G. Lyketsos, Bruce G. Pollock, Constantine Frangakis, Curtis L. Meinert, David M. Shade, Cynthia A. Munro, Gregory H. Pelton, Anton P. Porsteinsson, Lon S. Schneider, Jerome A. Yesavage, Devangere P. Devanand, Zahinoor Ismail, Peter V. Rabins, Lea T. Drye |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Activities of daily living Psychomotor agitation Citalopram Placebo Severity of Illness Index Article law.invention Double-Blind Method Randomized controlled trial Alzheimer Disease law Rating scale Regression toward the mean Activities of Daily Living Severity of illness medicine Humans Psychiatry Psychomotor Agitation Aged Aged 80 and over Psychiatric Status Rating Scales Placebo Effect Aggression Clinical trial Psychiatry and Mental health Clinical Psychology Treatment Outcome Caregivers Physical therapy Antidepressive Agents Second-Generation Female Geriatrics and Gerontology medicine.symptom Psychology Gerontology |
| Zdroj: | International Psychogeriatrics. 27:2059-2067 |
| ISSN: | 1741-203X 1041-6102 |
| DOI: | 10.1017/s1041610215001106 |
| Popis: | Background:Placebo responses raise significant challenges for the design of clinical trials. We report changes in agitation outcomes in the placebo arm of a recent trial of citalopram for agitation in Alzheimer's disease (CitAD).Methods:In the CitAD study, all participants and caregivers received a psychosocial intervention and 92 were assigned to placebo for nine weeks. Outcomes included Neurobehavioral Rating Scale agitation subscale (NBRS-A), modified AD Cooperative Study-Clinical Global Impression of Change (CGIC), Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain (NPI A/A) and Total (NPI-Total) and ADLs. Continuous outcomes were analyzed with mixed-effects modeling and dichotomous outcomes with logistic regression.Results:Agitation outcomes improved over nine weeks: NBRS-A mean (SD) decreased from 7.8 (3.0) at baseline to 5.4 (3.2), CMAI from 28.7 (6.7) to 26.7 (7.4), NPI A/A from 8.0 (2.4) to 4.9 (3.8), and NPI-Total from 37.3 (17.7) to 28.4 (22.1). The proportion of CGI-C agitation responders ranged from 21 to 29% and was significantly different from zero. MMSE improved from 14.4 (6.9) to 15.7 (7.2) and ADLs similarly improved. Most of the improvement was observed by three weeks and was sustained through nine weeks. The major predictor of improvement in each agitation measure was a higher baseline score in that measure.Conclusions:We observed significant placebo response which may be due to regression to the mean, response to a psychosocial intervention, natural course of symptoms, or nonspecific benefits of participation in a trial. |
| Databáze: | OpenAIRE |
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