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From the University of Washington (Drs. Teri and Logsdon) and Seattle Veterans Affairs Medical Center and the University of Washington (Dr. Peskind and Raskind), Seattle, WA; the University of Texas Southwestern Medical Center (Dr. Weiner), Dallas, TX; the University of California, San Diego, CA (Drs. Tractenberg, Grundman, Thomas, Schafer, and Thal); University of Michigan (Dr. Foster), Ann Arbor, MI; the University of Southern California (Dr. Schneider), Los Angeles, CA; Columbia University (Dr. Sano), New York, NY; the University Hospitals of Cleveland (Dr. Whitehouse), Cleveland, OH; the University of Rochester Medical Center (Dr. Tariot), Rochester, NY; University of Michigan and Ann Arbor Veterans Affairs Medical Center (Dr. Mellow), Ann Arbor, MI; Emory University (Dr. Auchus), Atlanta, GA; and members of the Alzheimer’s Disease Cooperative Study.
Address correspondence and reprint requests to Dr. Linda Teri, Department of Psychosocial and Community Health, Box 357263, University of Washington, Seattle, WA 98195-7263; e-mail: Lteri{at}u.washington.edu
BACKGROUND: Treatment of agitation is a crucial problem in the care of patients with AD. Although antipsychotic and antidepressant medications and behavior management techniques (BMT) have each been used to treat agitation, clinical trials of these treatments have been characterized by small sample sizes and uncontrolled treatment designs.
OBJECTIVE: To compare haloperidol, trazodone, and BMT with placebo in the treatment of agitation in AD outpatients.
METHODS: A total of 149 patients with AD and their caregivers participated in a randomized, placebo-controlled, multicenter trial. Blind assessment was conducted at baseline and after 16 weeks of treatment. The three active treatments were haloperidol, trazodone, and BMT. The Alzheimer’s Disease Cooperative Study Clinical Global Impression of Change was the primary outcome measure. Secondary outcomes included patient agitation, cognition, and function, and caregiver burden.
RESULTS: Thirty-four percent of subjects improved relative to baseline. No significant differences on outcome were obtained between haloperidol (mean dose, 1.8 mg/d), trazodone (mean dose, 200 mg/d), BMT, or placebo. Significantly fewer adverse events of bradykinesia and parkinsonian gait were evident in the BMT arm. No other significant difference in adverse events was seen. Symptoms did not respond differentially to the different treatments.
CONCLUSIONS: Comparable modest reductions in agitation occurred in patients receiving haloperidol, trazodone, BMT, and placebo. More effective pharmacologic, nonpharmacologic, and combination treatments are needed.
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