title: Treatment of agitation in AD: a randomized, placebo-controlled clinical trial.
abstract: 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.
authors.affiliation: University of Washington, Department of Psychosocial and Community Health, Seattle 98195-7263, USA. Lteri@u.washington.edu
authors.forename: L
authors.initials: L
authors.lastname: Teri
authors.forename: R G
authors.initials: RG
authors.lastname: Logsdon
authors.forename: E
authors.initials: E
authors.lastname: Peskind
authors.forename: M
authors.initials: M
authors.lastname: Raskind
authors.forename: M F
authors.initials: MF
authors.lastname: Weiner
authors.forename: R E
authors.initials: RE
authors.lastname: Tractenberg
authors.forename: N L
authors.initials: NL
authors.lastname: Foster
authors.forename: L S
authors.initials: LS
authors.lastname: Schneider
authors.forename: M
authors.initials: M
authors.lastname: Sano
authors.forename: P
authors.initials: P
authors.lastname: Whitehouse
authors.forename: P
authors.initials: P
authors.lastname: Tariot
authors.forename: A M
authors.initials: AM
authors.lastname: Mellow
authors.forename: A P
authors.initials: AP
authors.lastname: Auchus
authors.forename: M
authors.initials: M
authors.lastname: Grundman
authors.forename: R G
authors.initials: RG
authors.lastname: Thomas
authors.forename: K
authors.initials: K
authors.lastname: Schafer
authors.forename: L J
authors.initials: LJ
authors.lastname: Thal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000503:physiopathology* / Q000628:therapy*; D001521:Behavior Therapy; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011595:Psychomotor Agitation / Q000628:therapy*; D014196:Trazodone / Q000627:therapeutic use*
chemical_list: D006220:Haloperidol; D014196:Trazodone