The patients were randomly assigned to receive tamoxifen(Drug information on tamoxifen) (20-140 mg/day) or placebo for three weeks. Primary efficacy was assessed by the Young Mania Rating Scale.
The eight patients on tamoxifen showed significant improvement in mania compared with placebo as early as five days (d=0.59, 95% CI, 0.17-1.00), a 50% or greater effect that remained significant throughout the three-week trial (d=1.11, CI, 0.59-1.64).
The placebo group showed no significant change from baseline at any point.
After three weeks, the researchers said, the effect size for the drug difference was "very large" (d=1.08, 95% C.I., 0.45 to 1.71 (P=0.001).
