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Cited by 52Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsPharmaceutical Practices and Patient Outcomes

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Citalopram for agitation in Alzheimer's disease: Design and methods

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Drye, Lea T., Ismail, Zahinoor, Porsteinsson, Anton P., Rosenberg, Paul B., Weintraub, Daniel, Marano, Christopher, Pelton, Gregory, Frangakis, Constantine, Rabins, Peter V., Munro, Cynthia A., Meinert, Curtis L., Devanand, D.P., Yesavage, Jerome, Mintzer, Jacobo E., Schneider, Lon S., Pollock, Bruce G., Lyketsos, Constantine G., CitAD Research Group·2012·Alzheimer's & Dementia
DOI 10.1016/j.jalz.2011.01.007PMC PMC3333484
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Abstract

Background: Agitation is one of the most common neuropsychiatric symptoms of Alzheimer's disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence‐supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer's disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms. Methods: CitAD is a randomized, double‐masked, placebo‐controlled multicenter clinical trial, with two parallel treatment groups assigned in a 1:1 ratio and randomization stratified by clinical center. The study included eight recruiting clinical centers, a chair's office, and a coordinating center located in university settings in the United States and Canada. A total of 200 individuals having probable AD with clinically significant agitation and without major depression were recruited for this study. Patients were randomized to receive citalopram (target dose of 30 mg/d) or matching placebo. Caregivers of patients in both treatment groups received a structured psychosocial therapy. Agitation was compared between treatment groups using the NeuroBehavioral Rating Scale and the AD Cooperative Study‐ Clinical Global Impression of Change, which are the primary outcomes. Functional performance, cognition, caregiver distress, and rates of adverse and serious adverse events were also measured. Conclusion: The authors believe the design elements in CitAD are important features to be included in trials assessing the safety and efficacy of psychotropic medications for clinically significant agitation in AD.

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  • The study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo on NBRS-A, and >80% power for mADCS-CGIC.

    “For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo. For the mADCS-CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).”

    From Effect of Citalopram on Agitation in Alzheimer Disease: The CitAD Randomized Clinical Trial (2014) · cites this paper as [20]

    Section 2.9 supports at least 85% power for the NBRS outcome, but specifies a 3–5-point difference assessed longitudinally over nine weeks, not a 40% standardized difference at week 9. The same section supports greater than 80% power for the ADCS-CGIC proportional-odds analysis, using a 20% difference in the proportions who improve or worsen as a lower-bound calculation. (LLM, conf=0.89)

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Metadata

Authors
Drye, L. T., Ismail, Z., Porsteinsson, A. P., Rosenberg, P. B., Weintraub, D., Marano, C., Pelton, G., Frangakis, C., Rabins, P. V., Munro, C. A., Meinert, C. L., Devanand, D. P., Yesavage, J., Mintzer, J. E., Schneider, L. S., Pollock, B. G., Lyketsos, C. G., & CitAD Research Group
Affiliations
  • Johns Hopkins University (US)
  • University of Toronto (CA)
  • University of Rochester Medicine (US)
  • University of Pennsylvania (US)
  • New York State Psychiatric Institute (US)
  • United States Department of Veterans Affairs (US)
  • Medical University of South Carolina (US)
  • University of Southern California (US)
Corresponding author
Drye, Lea T.
ORCID
Venue
Alzheimer's & Dementia
Publisher
Wiley
Published
2012-02-03
Volume
8
Issue
2
Pages
121-130
ISSN
  • 1552-5260 (ISSN-L)
  • 1552-5279
DOI
10.1016/j.jalz.2011.01.007
PMC
PMC3333484
OpenAlex
W2032178361
Cited by
52
References
9
Citations by year
2026: 1 · 2025: 1 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 2 · 2020: 5 · 2019: 4 · 2018: 5 · 2017: 5 · 2016: 4 · 2015: 11 · 2014: 6 · 2013: 3
FWCI
3.99
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Alzheimer s & Dementia (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institute on Aging
  • National Institute of Mental Health (R01AG031348)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords
citalopram, Alzheimer's disease
MeSH terms
Alzheimer Disease, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Psychiatric Status Rating Scales, Psychomotor Agitation, Citalopram, Cognitive Behavioral Therapy, Outcome Assessment, Health Care, Selective Serotonin Reuptake Inhibitors

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