ABSENCE OF EFFECT OF SERTRALINE ON TIME-BASED SENSITIZATION OF COGNITIVE IMPAIRMENT WITH HALOPERIDOL

This double-blind, randomized, placebo-controlled study evaluated the effects of haloperidol alone and haloperidol plus sertraline on cognit ive and psychomotor function in 24 healthy male subjects. Method: All subjects received placebo on Day 1 and haloperidol 2 mg on Days 2 and 25. From Days 9 to 25, subjects were randomly assigned to either sertr aline (12 subjects) or placebo (12 subjects); the sertraline dose was titrated from 50 to 200 mg/day from Days 9 to 16, and remained at 200 mg/day for the final 10 days of the drug administration period. Cognit ive function testing Was performed before dosing and over a 24-hour pe riod after dosing on Days 1, 2, and 25. Results: Impairment of cogniti ve function was observed 6 to 8 hours after administration of haloperi dol on Day 2 but was not evident 23 hours after dosing. When single-do se haloperidol was given again 25 days later, greater impairment with earlier onset was noted in several tests in both treatment groups, sug gesting enhancement of this effect. There was no indication that sertr aline exacerbated the impairment produced by haloperidol since an equi valent effect also occurred in the placebo group. Three subjects (2 on sertraline and 1 on placebo) withdrew from the study because of side effects. Ten subjects in each group reported side effects related to t reatment. The side effect profiles of sertraline and of placebo were s imilar. Conclusion: Haloperidol produced a clear profile of cognitive impairment that was not worsened by concomitant sertraline administrat ion.