Usefulness of plasma haloperidol levels for monitoring clinical efficacy and side effects in Alzheimer patients with psychosis and behavioral dyscontrol.
OBJECTIVE
This study investigated whether measurement of plasma levels may be useful in monitoring clinical efficacy and side effects during oral haloperidol (HL) treatment of psychosis and behavioral dyscontrol in patients with Alzheimer disease (AD).


METHODS
After a single-blind placebo period of 1 week, 71 outpatients with AD were randomized to a 6-week, double-blind, placebo-controlled trial of HL 2 mg-3 mg/day (standard dose), HL 0.5 mg-0.75 mg/day (low dose), or placebo, with plasma levels for HL drawn at the end of 6 weeks.


RESULTS
Of the 40 patients who received active HL for 6 weeks, 35 had plasma levels drawn. Plasma levels were all below the lower limit of the postulated therapeutic range in schizophrenia. Nonetheless, HL plasma level significantly correlated with clinical efficacy as measured by reduction in Brief Psychiatric Rating Scale Total score, Psychosis factor, and Hostile-Suspiciousness factor, the Behavioral Syndromes Scale for Dementia Psychomotor Agitation scale, and with the severity of extrapyramidal side effects (EPS). Oral dose did not significantly correlate with any of these efficacy or side-effect measures. Plasma levels significantly correlated with HL dose. When both HL dose and HL plasma level were included as independent variables in linear-regression analyses, only HL plasma level was a significant predictor of efficacy and EPS.


CONCLUSIONS
Measurement of HL plasma levels may have potential usefulness as an adjunct in monitoring treatment response to oral HL in AD patients with psychosis or disruptive behavior.
Pelton
Gregory H
GH
Department of Biological Psychiatry, New York State Psychiatric Institute, New York, NY 10032, USA. ghp4@Columbia.edu
Devanand
Devangere P
DP
Bell
Karen
K
Marder
Karen
K
Marston
Kristin
K
Liu
Xinhua
X
Cooper
Thomas B
TB
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000523:psychology*; D014150:Antipsychotic Agents / Q000097:blood* / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006220:Haloperidol / Q000097:blood* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index
D014150:Antipsychotic Agents; D006220:Haloperidol