Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of a Phase 3, Randomized, Double-Blind Trial.
Gary S Sachs, Suresh Durgam, Willie R Earley et al.
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In 30 seconds
This post hoc analysis of a phase 3 randomized controlled trial evaluated the efficacy of adjunctive lumateperone 42 mg in patients aged 18-65 with major depressive disorder (MDD) and anxious distress. The study found that lumateperone significantly improved the Montgomery-Åsberg Depression Rating Scale (MADRS) Total score by a least squares mean difference of -6.8 compared to placebo at Day 43 in patients with anxious distress.
Key findings
- Lumateperone+ADT improved MADRS Total score by -6.8 in patients with anxious distress (P <.0001).
- Response and remission rates at Day 43 were significantly greater with lumateperone+ADT in both anxious distress subgroups (P <.05).
- Lumateperone+ADT significantly improved CGI-S score (P <.0001) and MADRS inner tension item (P <.001).
- Generalized Anxiety Disorder-7 score improved significantly in patients with anxious distress (P <.0001).
Why it matters
The findings suggest that adjunctive lumateperone may enhance treatment outcomes for patients with MDD who also experience anxious distress, a common and challenging comorbidity. Improved management of both depression and anxiety symptoms can lead to better overall patient care.