Lumateperone safe and effective for major depressive episodes in bipolar patients: Study

The key findings of this study were, when compared to placebo and the CGI-BP-S total score at day 43, lumateperone therapy was linked with a substantially higher improvement from baseline in MADRS score. Lumateperone outperformed placebo in terms of MADRS in both individuals with bipolar I and bipolar II illnesses. Somnolence and nausea were the only treatment-emergent side events that occurred at a clinically significant higher rate with lumateperone compared with placebo. The rate of extrapyramidal symptom-related treatment-emergent adverse events was modest and comparable to placebo. Weight, vital signs, metabolic and endocrine tests all showed minor alterations.

In conclusion, the results of this study are clearly an indication of the effectiveness of Lumateperone on depressive syndromes in patients with bipolar disorder and hence may be suggested for the treatment in such cases.

Reference:

Calabrese, J. R., Durgam, S., Satlin, A., Vanover, K. E., Davis, R. E., Chen, R., Kozauer, S. G., Mates, S., & Sachs, G. S. (2021). Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. American Journal of Psychiatry, appi.ajp.2021.2. https://doi.org/10.1176/appi.ajp.2021.20091339