ADVERTISEMENT
Lumateperone Improves Major Depressive Symptoms in Patients with Bipolar Disorder
Six weeks of daily lumateperone significantly improved depressive symptoms in patients with bipolar disorder experiencing a major depressive episode, according to study results published online ahead of print in The American Journal of Psychiatry.
“Significant MADRS [Montgomery-Åsberg depression rating scale] superiority for lumateperone over placebo was observed both in patients with bipolar I and bipolar II disorders,” researchers reported.
The double-blind study was a phase 3 trial that randomized 188 patients to 42 mg of daily lumateperone and 189 patients to daily placebo over 6 weeks. All participants were adults with bipolar I or bipolar II disorder who were experiencing a major depressive episode.
Frequent Manic Episodes Associated With Abnormal Fronto-Cortical Thinning in Bipolar Disorder
After 6 weeks of treatment, patients who received lumateperone showed significantly greater improvement on MADRS scores compared with placebo, the study found. Scores were an average 4.6 points lower among participants taking lumateperone compared with placebo. Slightly more than half of patients in the lumateperone group showed a 50% or greater decrease in MADRS scores from baseline compared with 36.7% of patients in the placebo group, Psychiatric News reported.
Lumateperone was also associated with significantly greater gains compared with placebo in total scores on the Clinical Global Impressions Scale–Bipolar Version severity scale, according to the study.
Lumateperone was generally well tolerated, researchers reported. Somnolence and nausea were the only treatment-emergent adverse events. Meanwhile, the incidence of extrapyramidal symptom-related treatment-emergent adverse events was low. Changes in weight, vital signs, and metabolic or endocrine assessments were minimal.
References
