At the end of the study, response rates were 63% for tamoxifen(Drug information on tamoxifen) (five of eight patients) and 13% (one of eight) for placebo (Fisher's Exact P=0.12), the researchers reported.
The tamoxifen group showed a decrease of 18.3 points from baseline to endpoint on the Young Mania scale, while the placebo patients' mania worsened 4.7 points. These findings support the results of an earlier single-blind study and that of other recent studies with tamoxifen, the researchers said.
Lorazepam (Ativan) was used during the trial for four of the tamoxifen patients and six of the placebo patients. And it has been suggested that the anti-manic effects seen with tamoxifen were related to the lorazepam(Drug information on lorazepam), which also has anti-manic effects. However, the researchers noted, lorazepam dose as a time-dependent covariate did not alter the tamoxifen results.
Overall, tamoxifen was well tolerated, they said, with loss of appetite the main side effect. Contrary to previous reports that tamoxifen might cause depression, the researchers said they found no such effect.