BACKGROUND: We compared three doses of a neuroleptic as a treatment for mania. METHOD: Forty-sevennewly admitted in-patients with mania were randomised to receive 10, 30, or 80 mg a day of oral haloperidol, under double-blind conditions for up to six weeks. All subjects received prophylactic benztropine. RESULTS: Repeated-measures analysis of variance and survival analysis showed no difference in outcome by the different doses. Excluding drop-outs (38%), most of whom left the study during the first two weeks, 72% of the subjects responded. Side-effects were minimal; there were no differences among the three doses. Non-responders received more adjunctive lorazepam than responders. CONCLUSIONS: The limited data suggest that more than 10 mg a day of haloperidol offers no advantage in mania.
RCT Entities:
BACKGROUND: We compared three doses of a neuroleptic as a treatment for mania. METHOD: Forty-seven newly admitted in-patients with mania were randomised to receive 10, 30, or 80 mg a day of oral haloperidol, under double-blind conditions for up to six weeks. All subjects received prophylactic benztropine. RESULTS: Repeated-measures analysis of variance and survival analysis showed no difference in outcome by the different doses. Excluding drop-outs (38%), most of whom left the study during the first two weeks, 72% of the subjects responded. Side-effects were minimal; there were no differences among the three doses. Non-responders received more adjunctive lorazepam than responders. CONCLUSIONS: The limited data suggest that more than 10 mg a day of haloperidol offers no advantage in mania.