Study design
All patients entered the hospital untreated with any medications. Patients were randomly allocated 23 to lithium + haloperidol+ ritanserin (Group A) or lithium + haloperidol + placebo (Group B) for a 6-week, double-blind, placebo-controlled study. Two patients from group A and one from group B dropped out from the study leaving 42 patients who met the DSM-IV criteria for manic episode. Rapid titration of lithium to therapeutic level 1–1.2 mEq/L was facilitated by the use of the pharmacokinetic method of predicting a therapeutic dose. Weekly lithium levels were obtained for compliance monitoring. Adjunctive antipsychotic medication that was haloperidol and was started simultaneously with lithium. The dose of haloperidol was titrated up to 10 mg/day. A fixed dose of ritanserin 10 mg/day was used throughout the study. Concomitant lorazepam use was restricted to a maximum dose of 2 mg/day for the first 4 days of treatment and thereafter by up to 1 mg/day for the next 6 days. Lorazepam was not permitted beyond the initial 10 days and was not allowed within 8 hours of the administration of mania rating scale. Biperiden was permitted to treat extrapyramidal symptoms up to a maximum of 6 mg/day throughout the course of the study. Biperiden was not allowed as prophylaxis for extrapyramidal symptoms. Patients were assessed by a third year resident of psychiatry at baseline and after 3, 7, 14, 21, 28 and 42 days after the medication started. Patients were hospitalized throughout the study.