Change in agitation in Alzheimer's disease in the placebo arm of a nine-week controlled trial

International Psychogeriatrics

Volumn 27, Issue 12, 2015, Pages 2059-2067

  Rosenberg, Paul B ^a   Drye, Lea T ^b   Porsteinsson, Anton P ^c   Pollock, Bruce G ^d,l   Devanand, D P ^e   Frangakis, Constantine ^b   Ismail, Zahinoor ^f,l   Marano, Christopher ^a   Meinert, Curtis L ^b   Mintzer, Jacobo E ^g,m,n   Munro, Cynthia A ^h   Pelton, Gregory ^e   Rabins, Peter V ⁱ   Schneider, Lon S ^j   Shade, David M ^b   Weintraub, Daniel ^k   Newell, Jeffery ^j   Yesavage, Jerome ^o,p   Lyketsos, Constantine G ^a  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^d CENTRE FOR ADDICTION AND MENTAL HEALTH   (Canada)

^e Columbia University ^*  (United States)

^f UNIVERSITY OF CALGARY   (Canada)

^g Roper St Francis Healthcare   (United States)

^h JOHNS HOPKINS UNIVERSITY   (United States)

ⁱ JOHNS HOPKINS HOSPITAL   (United States)

^j UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l UNIVERSITY OF TORONTO   (Canada)

^m MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

ⁿ RALPH H JOHNSON VA MEDICAL CENTER   (United States)

^o VA PALO ALTO HEALTH CARE SYSTEM   (United States)

^p STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

agitation; Alzheimer's disease; neuropsychiatric symptoms; randomized clinical trial

Indexed keywords

CITALOPRAM; LORAZEPAM; PLACEBO; TRAZODONE; ANTIDEPRESSANT AGENT;

AGED; AGITATION; AGITATION ASSESSMENT; ALZHEIMER DISEASE; ARTICLE; CAREGIVER; CLINICAL GLOBAL IMPRESSION OF CHANGE; COHEN MANSFIELD AGITATION INVENTORY; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR CLINICAL STUDY; MALE; NEUROBEHAVIORAL RATING SCALE AGITATION SUBSCALE; NEUROPSYCHIATRIC INVENTORY AGITATION/AGGRESSION; OUTCOME ASSESSMENT; PLACEBO EFFECT; PSYCHOSOCIAL CARE; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; AGGRESSION; DRUG EFFECTS; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; PSYCHOMOTOR AGITATION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; VERY ELDERLY;

ACTIVITIES OF DAILY LIVING; AGED; AGED, 80 AND OVER; AGGRESSION; ALZHEIMER DISEASE; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CAREGIVERS; CITALOPRAM; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PLACEBO EFFECT; PSYCHIATRIC STATUS RATING SCALES; PSYCHOMOTOR AGITATION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 84949535128     PISSN: 10416102     EISSN: 1741203X     Source Type: Journal    
DOI: 10.1017/S1041610215001106     Document Type: Article

References (38)

1. APA Work Group on Alzheimer's Disease, and other Dementias, et al. (2007). American psychiatric association practice guideline for the treatment of patients with Alzheimer's disease, and other dementias. 2nd edn. The American Journal of Psychiatry, 164, 5-56
2. Baer L., and Ivanova A. (2013). When should the sequential parallel comparison design be used in clinical trials? Clinical Investigation, 3, 823-833
3. Cohen-Mansfield J. (1996). Conceptualization of agitation: results based on the cohen-mansfield agitation inventory, and the agitation behavior mapping instrument. International Psychogeriatrics Association, 8 (Suppl. 3), 309-315, discussion 351-354
4. Cummings J. L., Mega M., Gray K., Rosenberg-Thompson S., Carusi D. A., and Gornbein J. (1994). The neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology, 44, 2308-2314
5. Drye L. T., et al. (2012). Citalopram for agitation in Alzheimer's disease: design, and methods. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 8, 121-130. DOI: 10.1016/j.jalz.2011.01.007
6. Folstein M. F., Folstein S. E. andMcHugh P. R. (1975). 'Mini-mental state'. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12, 189-198
7. Fox C., et al. (2012). Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. PloS one, 7, e35185. DOI: 10.1371/journal.pone.0035185
8. Galasko D. D., et al. (1997). An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's disease cooperative study. Alzheimer Disease, and Associated Disorders, 11 (Suppl. 2), S33-S39
9. Gauthier S., et al. (2010). Management of behavioral problems in Alzheimer's disease. International Psychogeriatrics Association, 22, 346-372. DOI: 10.1017/S1041610209991505
10. Gitlin L. N., Kales H. C., Lyketsos C. G. (2012). Nonpharmacologic management of behavioral symptoms in dementia. JAMA: The Journal of the American Medical Association, 308, 2020-2029. DOI: 10.1001/jama.2012.36918
11. Gitlin L. N., Marx K. A., Stanley I. H., Hansen B. R., and Van Haitsma K. S. (2014). Assessing neuropsychiatric symptoms in people with dementia: a systematic review of measures. International Psychogeriatrics Association, 26, 1805-1848. DOI: 10.1017/S1041610214001537
12. Gonfrier S., Andrieu S., Renaud D., Vellas B., and Robert P. H. (2012). Course of neuropsychiatric symptoms during a 4-year follow up in the REAL-FR cohort. The Journal of Nutrition, Health & Aging, 16, 134-137
13. Herrmann N., Gauthier S., Boneva N., Lemming O. M., and Lemming O. M. (2013). A randomized, double-blind, placebo-controlled trial of memantine in a behaviorally enriched sample of patients with moderate-to-severe Alzheimer's disease. International Psychogeriatrics Association, 25, 919-927. DOI: 10.1017/S1041610213000239
14. Kales H. C., Gitlin L. N., Lyketsos C. G., and Lyketsos C. G. (2014). Management of neuropsychiatric symptoms of dementia in clinical settings: recommendations from a multidisciplinary expert panel. Journal of the American Geriatrics Society, 62, 762-769. DOI: 10.1111/jgs.12730
15. Kales H. C., et al. (2007). Mortality risk in patients with dementia treated with antipsychotics versus other psychiatric medications. The American Journal of Psychiatry, 164, 1568-1576; quiz 1623. DOI: 10.1176/appi.ajp.2007.06101710
16. Kales H. C., et al. (2012). Risk of mortality among individual antipsychotics in patients with dementia. The American Journal of Psychiatry, 169, 71-79. DOI: 10.1176/appi.ajp.2011.11030347
17. Khan A., Faucett J., Lichtenberg P., Kirsch I., and Brown W. A. (2012). A systematic review of comparative efficacy of treatments, and controls for depression. PloS One, 7, e41778. DOI: 10.1371/journal.pone.0041778
18. Levin H. S., et al. (1987). The neurobehavioural rating scale: assessment of the behavioural sequelae of head injury by the clinician. Journal of Neurology, Neurosurgery, and Psychiatry, 50, 183-193
19. Lyketsos C. G., Lopez O., Jones B., Fitzpatrick A. L., Breitner J., and DeKosky S. (2002). Prevalence of neuropsychiatric symptoms in dementia, and mild cognitive impairment: results from the cardiovascular health study. JAMA : The Journal of the American Medical Association, 288, 1475-1483
20. Lyketsos C. G., Steinberg M., Tschanz J. T., Norton M. C., Steffens D. C., and Breitner J. C. (2000). Mental, and behavioral disturbances in dementia: findings from the cache county study on memory in aging. The American Journal of Psychiatry, 157, 708-714
21. Lyketsos C. G., et al. (2011). Neuropsychiatric symptoms in Alzheimer's disease. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 7, 532-539. DOI: 10.1016/j.jalz.2011.05.2410
22. Martin B. K., et al. (2006). Design of depression in Alzheimer's disease study-2. The American Journal of Geriatric Psychiatry, 14, 920-930. DOI: 10.1097/01.JGP.0000240977.71305.ee
23. McKhann G., Drachman D., Folstein M., Katzman R., Price D., and Stadlan E. M. (1984). Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA work group under the auspices of department of health, and human services task force on Alzheimer's disease. Neurology, 34, 939-944
24. Morris S.B. (2000). Distribution of the standardized mean change effect size for meta-analysis on repeated measures. The British Journal of Mathematical, and Statistical Psychology, 53 (Pt 1), 17-29
25. National Research Council. (2010). The Prevention, and Treatment of Missing Data in Clinical Trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral, and Social Sciences, and Education. Washington, DC: The National Academies Press
26. Pollock B.G., et al. (2002). Comparison of citalopram, perphenazine, and placebo for the acute treatment of psychosis, and behavioral disturbances in hospitalized, demented patients. The American Journal of Psychiatry, 159, 460-465
27. Pollock B.G., et al. (2007). A double-blind comparison of citalopram, and risperidone for the treatment of behavioral, and psychotic symptoms associated with dementia. The American Journal of Geriatric Psychiatry, 15, 942-952
28. Porsteinsson A.P., et al. (2014). Effect of citalopram on agitation in Alzheimer disease. JAMA : The Journal of the American Medical Association, 311, 682. DOI: 10.1001/jama.2014.93
29. Rosenberg P. B., Mielke M. M., and Lyketsos C. G. (2005). Caregiver assessment of patients' depression in Alzheimer disease: longitudinal analysis in a drug treatment study. The American Journal of Geriatric Psychiatry, 13, 822-826. DOI: 10.1176/appi.ajgp.13.9.822
30. Rosenberg P. B., et al. (2010). Sertraline for the treatment of depression in Alzheimer disease. The American Journal of Geriatric Psychiatry, 18, 136-145. DOI: 10.1097/JGP.0b013e3181c796eb
31. Rosenberg P. B., et al. (2013). Safety, and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial. The Journal of Clinical Psychiatry, 74, 810-816. DOI: 10.4088/JCP.12m08099
32. Schneider L. S., Dagerman K. S., and Insel P. (2005). Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA: The Journal of the American Medical Association, 294, 1934-1943. DOI: 10.1001/jama.294.15.1934
33. Schneider L. S., et al. (1997). Validity, and reliability of the Alzheimer's disease cooperative study-clinical global impression of change. The Alzheimer's disease cooperative study. Alzheimer Disease, and Associated Disorders, 11 (Suppl. 2), S22-S32
34. Schneider L. S., et al. (2006). Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. The New England Journal of Medicine, 355, 1525-1538. DOI: 10.1056/NEJMoa061240
35. Sommer O. H., Aga O., Cvancarova M., Olsen I. C., Selbaek G., and Engedal K. (2009). Effect of oxcarbazepine in the treatment of agitation, and aggression in severe dementia. Dementia, and Geriatric Cognitive Disorders, 27, 155-163. DOI: 10.1159/000199236
36. Steinberg M., et al. (2006). Risk factors for neuropsychiatric symptoms in dementia: the cache county study. International Journal of Geriatric Psychiatry, 21, 824-830
37. Steinberg M., et al. (2008). Point, and 5-year period prevalence of neuropsychiatric symptoms in dementia: the cache county study. International Journal of Geriatric Psychiatry, 23, 170-177. DOI: 10.1002/gps.1858
38. Trzepacz P. T., et al. (2013). Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease. International Psychogeriatrics Association, 25, 707-719. DOI: 10.1017/S1041610212002141