A pilot study of rapid lithium administration in the treatment of acute mania

Objectives: The use of rapid lithium dosage administration, a strategy that could lead to rapid improvement in mania, has been largely unexamined. In this open-label, pilot, acute-treatment study, we sought to determine the s afety and tolerability of lithium administered at 20 mg/kg/day. A secondary aim was to provide preliminary data regarding the efficacy of this strateg y in ameliorating manic, depressive, and psychotic symptoms. Methods: Fifteen patients hospitalized with DSM-IV bipolar disorder, manic or mixed, and who provided written informed consent, received lithium 20 mg /kg/day for up to 10 days. Patients were evaluated for adverse effects dail y. Lithium levels were obtained on days 2, 3, 4, 5, 7, and 10 or at study t ermination. Electrocardiograms (EKCs) were performed at baseline and on day s 1-5, 7, and 10 or at study termination. Symptomatic improvement was asses sed daily using the Young Mania Rating Scale, 24-item Hamilton Depression R ating Scale, and the Scale for Assessment of Positive Symptoms (SAPS). Results: Five of the 15 patients completed the 10-day study period. Two pat ients dropped out due to adverse events. Seven patients did not complete th e inpatient trial because of improvement sufficient to allow hospital disch arge. All patients achieved serum lithium concentrations greater than or eq ual to 0.6 mEq/L after 1 day of treatment; the mean +/- SD concentration on day 5 was 1.1 (+/- 0.1) mEq/L on day 5. There were significant reductions from baseline to endpoint on all rating scales, except the SAPS bizarre beh avior subscale. Conclusions: These pilot data suggest that lithium 20 mg/kg/day was well to lerated and that this strategy may produce rapid improvement in affective a nd psychotic symptoms. These impressions require confirmation in double-bli nd. randomized trials.