Citalopram for agitation in Alzheimer's disease: design and methods.
Author(s): Drye LT, Ismail Z, Porsteinsson AP, Rosenberg PB, Weintraub D, Marano C, Pelton
G, Frangakis C, Rabins PV, Munro CA, Meinert CL, Devanand DP, Yesavage J, Mintzer
JE, Schneider LS, Pollock BG, Lyketsos CG; CitAD Research Group.
Collaborators: Lyketsos C, Avramopoulos D, Munro C, Rabins P, Roche A, Shade D,
Meinert C, Casper AS, Drye L, Frangakis C, Jenkins G, Pan HM, Tonascia S,
Topaloglu O, Vaidya V, Ryan L, Rosenberg P, Pedroso J, Smith L, Steinberg M,
Devanand DP, Cunqueiro K, Pelton G, Mintzer J, Flynn-Longmire C, Gandy A,
Hatchell M, Lucas S, Brawman-Mintzer O, Modlin T, Russell S, Safrit E, Stuckey M,
Weichsel R, Williams A, Weintraub D, Czerniakowski J, DiFilippo S, Mamikonyan E,
Streim J, Porsteinsson A, Cosman K, Goldstein B, Ismail S, Kowalski N, Romeo T,
Salem-Spencer S, Stear K, Yesavage J, Ashford W, Bratcher K, Friedman L,
Georgette G, Gere E, Kim E, Newell J, Periyakoil V, Traum A, Vicencio A, Wicks D,
Pollock BG, Ismail Z, Miranda D, Mulsant BH, Nguyen MQ, Rajji T, Schneider LS,
Becerra M, Dagerman K, Pawluczyk S, Spann B, Teodoro L.
Affiliation(s): Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health,
Baltimore, MD, USA. ldrye@jhsph.edu
Publication date & source: 2012, Alzheimers Dement. , 8(2):121-30
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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