A double-blind dose-determination study with flutroline: A new neuroleptic
In a 4-wk double-blind clinical trial four doses (1, 5, 10, and 20 mg) of flutroline were compared in newly admitted schizophrenic patients. Although there were few statistically significant differences among the four dosage groups, there were at least five indications of greater therapeutic effectiveness in the higher dosages. The most favorable changes were seen in the 20-mg group, which was the only group to show improvement in all five factors of the Brief Psychiatric Rating Scale and in which a significant elevation of serum prolactin level occurred at a 6-hr post-dose sampling. In a previous clinical trial in which three different daily doses of flutroline (1, 20, and 100 mg) were compared, 20 and 100 mg were found to be equal in their therapeutic effects and superior to 1 mg. Since no dosage between 1 and 20 mg were employed, the possibility that therapeutic effects with flutroline may already be present in daily doses below 20 mg could not be ignored. While the present findings are in favor of this contention, they also indicate that therapeutic efficacy with 20 mg is greater than with 1-, 5-, or 10-mg daily doses.
Wilson, WH; Guy, W; Ban, TA
Drug Development Research
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