Intra-Cellular Therapies has encouraging results from its Phase 3 clinical trial evaluating lumateperone as an adjunctive therapy to antidepressants in patients with Major Depressive Disorder (MDD). In a population of 485 individuals with MDD, the group tested whether 42 mg/day of lumateperone reduced MDD symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) and/or the Clinical Global Impression Scale for Severity of Illness (CGI-S) at 6 weeks of daily treatment.
Intra-Cellular Therapies found that this dosing of lumateperone (Figure) significantly decreased total scores on both the MADRS and CGI-s compared to placebo at Week 6 of treatment (p<0.0001; Cohen’s d effect size = 0.61 and p<0.0001; effect size = 0.67, respectively). Patients also reported improvements on the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale (p<0.0001). Importantly, significant efficacy was observed as early as Week 1 and maintained throughout the study.
Lumateperone also demonstrated a favorable safety and tolerability profile consistent with prior trials. The most reported adverse effects (>5% incidence rate; at more than twice the rate of placebo) were dry mouth (10.8%), fatigue (9.5%) and tremor (5.0%), which were mostly mild to moderate in severity and typically resolved within a short period of time. These adverse events were like those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia.
These results are promising given the challenges in treating MDD and the limited efficacy of existing therapies, underscoring the potential of lumateperone to address unmet needs in MDD treatment. A second Phase 3 study will be finished in the second quarter of this year, so stay tuned to whether it also achieves positive results!
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