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Am J Psychiatry 1997; 154:1057-1062
Copyright © 1997 by American Psychiatric Association
Relative efficacy of haloperidol and pimozide in children and adolescents with Tourette's disorder
FR Sallee, L Nesbitt, C Jackson, L Sine and G Sethuraman
Institute of Psychiatry, Charleston, SC 29425, USA.
OBJECTIVE: The authors evaluated the relative efficacy and safety of
pimozide and haloperidol in the treatment of Gilles de la Tourette's
syndrome in children and adolescents. METHOD: A double-blind, 24-week,
placebo-controlled double crossover study of equivalent dose formulations
of haloperidol and pimozide was conducted with 22 subjects, aged 7-16
years, with Tourette's disorder who were randomly assigned to first one
active drug treatment and then the other. Biweekly assessment and flexible
dose titration mimicked clinical practice. The primary outcome variable was
total score on the Tourette Syndrome Global Scale. Final outcome was
determined after 6 weeks of each treatment (placebo, pimozide,
haloperidol), with a 2-week placebo baseline period and intervening 2-week
placebo washout periods between treatments. RESULTS: Pimozide proved
significantly different from placebo in affecting the primary outcome
variable, whereas haloperidol failed to have a significant effect.
Haloperidol exhibited a threefold higher frequency of serious side effects
and significantly greater extrapyramidal symptoms relative to pimozide.
Haloperidol-associated treatment-limiting adverse events were experienced
by 41% of the patients. The therapeutic doses of pimozide and haloperidol
were equivalent (mean = 3.4 mg/day, SD = 1.6, and mean = 3.5 mg/day, SD =
2.2, respectively). CONCLUSIONS: At equivalent doses, pimozide is superior
to haloperidol for controlling symptoms of Tourette's disorder in children
and adolescents.
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