Approximately 5-20% of psychiatric patients hospitalized in public facilities receive long-term, high-dose antipsychotic treatment. Most of these patients &e prescribed the high-dose treatment because they have severe symptoms of schizophrenia. This treatment, associated with higher risk for side effects, was not demonstrated to be therapeutically more effective than the (lower) standard dosage regimens. Plasma level of 10 ng/ml of haloperidol (approximately 18 mg/day by mouth) was demonstrated to provide sufficient antipsychotic effects in schizophrenic patients. The main goals of the current proposal are to identify schizophrenic inpatients receiving long-term high dose haloperidol treatment; to reduce their plasma levels gradually and under controlled conditions to 10 ng/ml, and to determine the effects of that reduction. The subjects will be 290 schizophrenic inpatients whose treating psychiatrists prescribed oral doses of haloperidol yielding plasma levels greater than 15 ng/ml. Patients will be randomly assigned to one of two groups: level reduction or level continuation. The patients in the first group will have their doses reduced over a period of 12 weeks; the target plasma level will be 10 ng/ml. They will be maintained on that level for the subsequent 16 weeks. The patients in the continuation group will be maintained on their level for 28 weeks. Any relapsing patients will have their medication adjusted. Comparison of these groups outcomes will show whether the high doses were needed. A subgroup of patients who need the high-dose treatment may be identified and characterized. Proposed 5-year study will provide a rational basis for the dosage regimens of typical neuroleptics in the treatment of severe forms of schizophrenia.
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