In Bipolar Disorder, Lumateperone Improves Function, Quality of Life

Lumateperone therapy has been found to improve function and quality of life among patients with bipolar disorder (BD) experiencing a major depressive episode. These findings were presented at Psych Congress 2022, held from September 17 to 20, 2022, in New Orleans, Louisiana.

Compared with the general population or patients with other mood disorders, BD is associated with more functional disability and poorer quality of life. Lumateperone modulates serotonin, dopamine, and glutamate neurotransmission and is approved for the treatment of schizophrenia and depressive episodes associated with BD.

This analysis evaluated functional disability and quality of life among participants in a phase 3, randomized, double-blind, parallel-group, placebo-controlled, multinational study (ClinicalTrails.gov Identifier: NCT03249376). Patients (N=376) with BD I or BD II experiencing a major depressive episode were randomly assigned in a 1:1 ratio to receive 42 mg lumateperone or placebo once daily for 6 weeks. The primary endpoints were change in Montgomery-Åsberg Depression Rating Scale (MADRS) and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) scores from baseline.

Intervention and control cohorts comprised 52.7% and 63.3% women; mean age 45.7 (range, 18-72) and 44.1 (range, 18-72) years; 92.0% and 90.4% were White; they were diagnosed at age 33.2 (range, 5-62) and 32.0 (range, 11-63) years; and 88.3% and 88.8% had up to 9 lifetime major depressive episodes, respectively.

The lumateperone cohort was found to have significant improvement in MADRS scores from baseline compared with placebo (P <.0001), occurring as early as day 8 of treatment.

Similarly, Q-LES-Q-SF scores improved among lumateperone group compared with placebo (P =.0012). Stratified by Q-LES-Q-SF domains, at day 43, significant group differences were observed for mood; household activities; social relationships; family relationships; leisure time activities; ability to function in daily life (all P <.01); sexual drive, interest, and/or performance; and overall sense of well-being (both P <.05).

More of the lumateperone cohort shifted from very poor or poor to good or very good for mood, physical health, household activities, and social relationships domains than were observed in the placebo group.

The major limitation of this study is the short treatment duration.

“Lumateperone 42 mg significantly improved quality of life and functional impairment in patients with a major depressive episode associated with bipolar I and bipolar II disorder,” the study authors noted. “These results support lumateperone as treatment for major depressive episodes associated with bipolar I or bipolar II disorder.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.