Abstract
Introduction
Lumateperone, an atypical antipsychotic drug approved for Bipolar II depression in 2021, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.
Objectives
This post-hoc analysis of an Indian Phase 3 study was conducted to evaluate the impact of Lumateperone 42mg compared to Quetiapine 300mg on quality of life of patients with Bipolar II depression assessed via Quality-of-life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF).
Methods
The phase-III, randomized, multi-centric, assessor-blind, parallel-group, active-controlled, comparative, non-inferiority study included patients with Bipolar II depression with moderate severity having a Montgomery-Asberg depression rating scale (MADRS) score ≥20 and Clinical global impression–bipolar version–severity (CGI-BP-S) score ≥4. The study was conducted after receiving regulatory and ethics committee approvals. The patients were randomized (1:1) to either receive Lumateperone 42mg [Test] or Quetiapine 300mg [Comparator] for 6 weeks. This post-hoc analysis evaluated Q-LES-Q-SF total score and individual item scores [Physical health(1), Mood(2), Work(3), Household activities(4), Social relationships(5), Family relationships(6), Leisure time activities(7), Ability to function in daily life(8), Sexual drive, interest and/or performance(9), Economic status(10), Living/housing situation(11), Ability to get around physically(12), Ability to do work(13), Overall sense of wellbeing(14), and Overall life satisfaction and contentment(16)] for efficacy outcomes and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]
Results
This post-hoc analysis included 462 patients [231 each in Test and Comparator]. The baseline demographic characteristics were comparable in between treatment arms. The improvement in Q-LES-Q-SF (total score and individual item scores) is significant from baseline to Day 42 in both treatment arms and comparable [Figure 1 and Figure 2 respectively]. Statistically significant improvement in Test over Comparator was observed for Item 7 (Leisure time activities) and Item 14 (Overall sense of wellbeing) [Figure 2]. The incidence of TEAEs were similar in both treatment arms [Test: 34.6%; Comparator: 35.5%] and no serious adverse events were reported.
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Image 2:
Conclusions
This post-hoc analysis demonstrated that Lumateperone 42mg is comparable to Quetiapine 300mg in treatment of Bipolar II depression as assessed via Q-LES-Q-SF score from baseline to Day 42, and both treatments were found to be well tolerated.
Disclosure of Interest
A. Dharmadhikari: None Declared, P. Chaurasia: None Declared, Y. Patel: None Declared, D. Choudhary: None Declared, P. Dasud: None Declared, M. Bhirud: None Declared, P. Meena: None Declared, F. Shah: None Declared, G. Ganesan: None Declared, B. P. Rathour: None Declared, K. Mistry: None Declared, M. Dutta: None Declared, A. Ramaraju: None Declared, S. Mangalwedhe: None Declared, S. G. Goyal: None Declared, G. Kulkarni: None Declared, A. Mukhopadhyay: None Declared, P. Chaudhary: None Declared, G. T. Harsha: None Declared, M. Parikh: None Declared, S. Dey: None Declared, S. Sarkhel: None Declared, N. Jyothi: None Declared, A. Kumar: None Declared, N. Sooch: None Declared, A. Shetty Employee of: Sun Pharma, S. Saha Employee of: Sun Pharma, P. Devkare Employee of: Sun Pharma, A. Shetty Employee of: Sun Pharma, D. Patil Employee of: Sun Pharma, P. Ghadge Employee of: Sun Pharma, A. Mane Employee of: Sun Pharma, S. Mehta Employee of: Sun Pharma