RELATIVE EFFICACY OF HALOPERIDOL AND PIMOZIDE IN CHILDREN AND ADOLESCENTS WITH TOURETTES DISORDER

Objective: The authors evaluated the relative efficacy and safety of p imozide and haloperidol in the treatment of Gilles de la Tourette's sy ndrome in children and adolescents. Method: A double-blind 24-week, pl acebo-controlled double crossover study of equivalent dose formulation s of haloperidol and pimozide was conducted with 22 subjects, aged 7-1 6 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 outcom e variable was total score on the Tourette Syndrome Global Scale. Fina l outcome was determined after 6 weeks of each treatment (placebo, pim ozide, haloperidol), with a 2-week placebo baseline period and interve ning 2-week placebo washout periods between treatments. Results: Pimoz ide proved significantly different from placebo in affecting the prima ry 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 relativ e to pimozide. Haloperidol-associated treatment-limiting adverse event s were experienced by 41% of the patients. The therapeutic doses of pi mozide and haloperidol were equivalent (mean=3.4 mg/day, SD=1.6, and m ean=3.5 mg/day, SD=2.2, respectively). Conclusions: At equivalent dose s, pimozide is superior to haloperidol for controlling symptoms of Tou rette's disorder in children and adolescents.