Citalopram for agitation in Alzheimer's disease: design and methods.
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.


CONCLUSIONS
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.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. ldrye@jhsph.edu
Lea T
LT
Drye
Zahinoor
Z
Ismail
Anton P
AP
Porsteinsson
Paul B
PB
Rosenberg
Daniel
D
Weintraub
Christopher
C
Marano
Gregory
G
Pelton
Constantine
C
Frangakis
Peter V
PV
Rabins
Cynthia A
CA
Munro
Curtis L
CL
Meinert
D P
DP
Devanand
Jerome
J
Yesavage
Jacobo E
JE
Mintzer
Lon S
LS
Schneider
Bruce G
BG
Pollock
Constantine G
CG
Lyketsos
D000544:Alzheimer Disease / Q000150:complications*; D015283:Citalopram / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology* / Q000534:rehabilitation; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors