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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.

Haloperidol levels in blood were measured in 55 acutely psychotic inpatients with schizophrenia, who were randomly assigned to three fixed doses of oral haloperidol. Nineteen of these subjects received 10 mg/day, 18 received 30 mg/day, and 18 of them received 80 mg/day. All of the subjects were treated under double-blind conditions for 6 weeks or until remission. Haloperidol and reduced haloperidol levels were measured in plasma and red blood cells at the end of 2, 4, and 6 weeks of treatment. There were statistically significant linear correlations between the dose of haloperidol and levels in blood. An examination of data for linear and curvilinear relationships between levels in blood and clinical response did not yield any statistically significant relations. The data did not support the concept of a "therapeutic window." The ratio of reduced haloperidol to haloperidol levels in plasma or red blood cells did not yield any statistically significant correlations to clinical outcome.

Eighty-seven newly admitted inpatients with schizophrenia were randomized to receive 10, 30, or 80 mg/d of oral haloperidol. They were treated under double-blind conditions for 6 weeks, less if their acute symptoms remitted sooner. Survival analysis showed no differences among the three treatments. Side effects were minimal in all three treatment groups, and there were no differences in side effects among the groups. These results suggest that dosages higher than 10 mg/d of haloperidol for most patients have no additional beneficial effect in the treatment of acute or exacerbated schizophrenia.

Three doses of haloperidol, 10 mg/day, 30 mg/day, and 80 mg/day, were compared in 47 newly admitted manic patients. There was no difference in outcome within 6 weeks among the three doses. Four blood levels of plasma and red blood cell (RBC) haloperidol and reduced haloperidol showed no linear or curvilinear relationships to clinical response.