Side effects associated with lithium and placebo administration in aggressive children.

This study represents a secondary data analysis of two double-blind and placebo-controlled clinical trials of lithium, performed to contrast side effects associated with lithium administration to those associated with placebo. The sample consisted of 91 hospitalized children, aged 5.12 to 12.92 years (mean 9.16), diagnosed as having conduct disorder characterized by severe aggressiveness and explosiveness. Daily doses of lithium ranged from 250 to 2100 mg. During the entire treatment period, more side effects were seen in the lithium group than in the placebo group, whereas during the therapeutic dose period, the difference between side effects in the two groups diminished. The most common side effects seen exclusively with lithium administration included enuresis, fatigue, and ataxia. Increased aggressiveness was observed in 4 children who received placebo. Vomiting, headache, and stomachache were the most common side effects experienced by patients in both lithium and placebo groups. However, more patients experienced these side effects in the lithium group than in the placebo group.