Lumateperone, an atypical antipsychotic drug, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.

This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on age (18-45, >45-65).

The phase-III, randomized, multi-centric, assessor-blind, parallel-group, active-controlled, comparative, non-inferiority study included Indian 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. The patients were stratified based on age: Subgroup 1 [S1]: 18-45 years and Subgroup 2 [S2]: >45-65 years. For efficacy outcomes MADRS score, CGI-BP-S (total score, depression subscore and overall bipolar illness subscore), and Quality of life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) score were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 462 patients, out of which 320 in S1[Test=159; Comparator=161] and 142 in S2[Test=72; Comparator=70]. The baseline demographic characteristics were comparable in between treatment arms across subgroups. The primary endpoint of reduction in MADRS score from baseline to Day 42 in Test arm was non-inferior to Comparator arm in both subgroups [Figure 1] as the upper 95% CI was below the pre-defined margin of 3.0. The reduction of CGI-BP-S (total score, depression subscore and overall bipolar illness subscore) from Day 14 to Day 42 were comparable in both Test and Comparator arms in both subgroups. The improvement in Q-LES-Q-SF score from baseline to Day 42 were comparable in both Test and Comparator arms in both subgroups. The incidence of TEAEs were comparable in both treatment arms [S1: Test=31.4% and Comparator=36.6%; S2: Test=41.7% and Comparator=32.9%] and no serious adverse events were reported.

Image 1:

This subgroup analysis demonstrated that Lumateperone 42mg is non-inferior to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, irrespective of age of the patients and both treatments were found to be well tolerated. Hence, Lumateperone can be considered as valuable treatment option in management of Bipolar II depression.

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

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.

This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on mixed symptoms assessed via Young Mania Rating Scale (YMRS).

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. The patients were stratified based on YMRS: Subgroup 1 [S1]: ≤6 and Subgroup 2 [S2]: >6 to 12. For efficacy outcomes MADRS score, CGI-BP-S (total score, depression subscore and overall bipolar illness subscore), and Quality of life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) score were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 235 patients in S1[Test=109; Comparator=126] and 227 in S2[Test=122; Comparator=105]. The baseline demographic characteristics were comparable in between treatment arms across subgroups. The primary endpoint of reduction in MADRS score from baseline to Day 42 in Test arm was non-inferior to Comparator arm in both subgroups [Figure 1] as the upper 95% CI was below the pre-defined margin of 3.0. The reduction of CGI-BP-S (total score, depression subscore and overall bipolar illness subscore) from Day 14 to Day 42 were comparable in both Test and Comparator arms in both subgroups. The improvement in Q-LES-Q-SF score from baseline to Day 42 were comparable in both Test and Comparator arms in both subgroups. The incidence of TEAEs were similar in both treatment arms [S1: Test=28.4% and Comparator=28.6%; S2: Test=40.2% and Comparator=43.8%] and no serious adverse events were reported.

Image 1:

This subgroup analysis demonstrated that Lumateperone 42mg is non-inferior to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, irrespective of presence of mixed symptoms and both treatments were found to be well tolerated.

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.

Lumateperone, an atypical antipsychotic drug, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.

This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on disease duration.

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. The patients were stratified based on disease duration: Subgroup 1 [S1]: ≤6 months and Subgroup 2 [S2]: >6 months. For efficacy outcomes MADRS score, CGI-BP-S (total score, depression subscore and overall bipolar illness subscore), and Quality of life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) score were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 462 patients, out of which 118 in S1[Test=62; Comparator=56] and 344 in S2[Test=169; Comparator=175]. The baseline demographic characteristics were comparable in between treatment arms across subgroups. The primary endpoint of reduction in MADRS score from baseline to Day 42 in Test arm was non-inferior to Comparator arm in both subgroups [Figure 1] as the upper 95% CI was below the pre-defined margin of 3.0. The reduction of CGI-BP-S (total score, depression subscore and overall bipolar illness subscore) from Day 14 to Day 42 were comparable in both Test and Comparator arms in both subgroups. The improvement in Q-LES-Q-SF score from baseline to Day 42 were comparable in both Test and Comparator arms in both subgroups. The incidence of TEAEs were similar in both treatment arms [S1: Test=30.6% and Comparator=30.4%; S2: Test=36.1% and Comparator=37.1%] and no serious adverse events were reported.

Image 1:

This subgroup analysis demonstrated that Lumateperone 42mg is non-inferior to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, irrespective of chronicity of the disease and both treatments were found to be well tolerated. Hence, Lumateperone can be considered as valuable treatment option in management of Bipolar II depression.

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.

Lumateperone, an atypical antipsychotic drug, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.

This post-hoc analysis of an Indian Phase 3 study was conducted to evaluate the impact of Lumateperone 42mg compared to Quetiapine 300mg on severity of depression assessed via MADRS in patients with Bipolar II depression.

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 MADRS total score and individual items from Question 1 to Question 10 i.e. (Q1) Apparent sadness; (Q2) Reported sadness; (Q3) Inner tension; (Q4) Reduced sleep; (Q5) Reduced appetite; (Q6) Concentration difficulties; (Q7) Lassitude; (Q8) Inability to feel; (Q9) Pessimistic thoughts; and (Q10) Suicidal thoughts respectively and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 462 patients, out of which 231 were in the Test group and 231 in the comparator group. The baseline demographic characteristics were comparable in between treatment arms. The reduction in MADRS score (total and individual items) from baseline to Day 42 in Test arm was comparable to Comparator arm [Figure 1 & 2]. The incidence of TEAEs were similar in both treatment arms [Test: 34.6%; Comparator: 35.5%] and no serious adverse events were reported.

Image 1:

Image 2:

This post-hoc analysis demonstrated that Lumateperone 42mg is comparable to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, and both treatments were found to be well tolerated. Hence, Lumateperone can be considered as valuable treatment option in management of Bipolar II depression.

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.

Lumateperone, an atypical antipsychotic drug approved in 2021 for bipolar depression, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors. In India, Quetiapine is one of the approved drugs for use in depressive episodes for bipolar disorder.

This post-hoc analysis of an Indian Phase 3 study was conducted to evaluate the correlation of severity of depression assessed via Montgomery-Asberg depression rating scale (MADRS) and severity of hypomania symptoms via Young Mania Rating Scale (YMRS) when treated with Lumateperone 42mg or Quetiapine 300mg.

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 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. In this post-hoc analysis, correlation between MADRS and YMRS were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This post-hoc analysis included 462 patients [231 each in Test and Comparator]. The baseline demographic characteristics were comparable in between treatment arms. The Pearson’s correlation coefficient between change from baseline in MADRS score and YMRS score was statistically significant for both treatment arms at Day 42 [Test: 0.3144, p<0.0001; Comparator: 0.3284, p<0.0001] and the linear regression between 2 arms was not statistically significant (p=0.4203), indicating weak positive correlation between the 2 scales [Figure 1 and 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.

Image 1:

Image 2:

This post-hoc analysis demonstrated that patients with Bipolar II depression when treated with Lumateperone 42mg or Quetiapine 300mg, the reduction in MADRS score is directly proportional to reduction in YMRS score and both treatments were well tolerated.

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

Lumateperone, an atypical antipsychotic drug approved in 2021 for bipolar depression, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors. In India, Quetiapine is one of the approved drugs for use in depressive episodes for bipolar disorder.

This post-hoc analysis of an Indian Phase 3 study was conducted to evaluate the correlation of severity of depression assessed via Montgomery-Asberg depression rating scale (MADRS) and quality of life assessed via Quality-of-life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) when treated with Lumateperone 42mg or Quetiapine 300mg.

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 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. In this post-hoc analysis, correlation between MADRS and Q-LES-Q-SF were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This post-hoc analysis included 462 patients [231 each in Test and Comparator]. The baseline demographic characteristics were comparable in between treatment arms. The Pearson’s correlation coefficient between change from baseline in MADRS score and Q-LES-Q-SF score was statistically significant for both treatment arms at Day 42 [Test: -0.192, p=0.0043; Comparator: -0.299, p<0.0001] and the linear regression between 2 arms was not statistically significant (p=0.0853), indicating weak negative correlation between the 2 scales [Figure 1 and 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.

Image 1:

Image 2:

This post-hoc analysis demonstrated that patient with Bipolar II depression when treated with Lumateperone 42mg or Quetiapine 300mg, the reduction in MADRS score is inversely proportional to Q-LES-Q-SF score.

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. G. Goyal: None Declared, S. Mangalwedhe: 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, S. Saha Employee of: Sun Pharma, A. Shetty 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

Lumateperone, an atypical antipsychotic drug approved in 2021 for bipolar depression, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors. In India, Quetiapine is one of the approved drugs for use in depressive episodes for bipolar disorder.

This post-hoc analysis of an Indian Phase 3 study was conducted to evaluate the correlation of quality of life assessed via Quality-of-life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) and severity of hypomania symptoms via Young Mania Rating Scale (YMRS) when treated with Lumateperone 42mg or Quetiapine 300mg.

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. In this post-hoc analysis, correlation between Q-LES-Q-SF and YMRS were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This post-hoc analysis included 462 patients [231 each in Test and Comparator]. The baseline demographic characteristics were comparable in between treatment arms. The Pearson’s correlation coefficient between Q-LES-Q-SF score and YMRS score was statistically significant for both treatment arms at Day 42 [Test: -0.268, p<0.0001; Comparator: -0.281, p<0.0001] and the linear regression between 2 arms was not statistically significant (p=0.8603), indicating weak negative correlation between the 2 scales [Figure 1 and 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.

Image 1:

Image 2:

This post-hoc analysis demonstrated that patients with Bipolar II depression when treated with Lumateperone 42mg or Quetiapine 300mg, the improvement in Q-LES-Q-SF score is inversely proportional to YMRS score and both treatments were well tolerated.

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

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.

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).

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]

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.

Image 1:

Image 2:

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.

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

Lumateperone, an atypical antipsychotic drug, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.

This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on baseline body mass index (BMI).

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. The patients were stratified based on baseline BMI: Subgroup 1 [S1]: <25Kg/m2 and Subgroup 2 [S2]: ≥25Kg/m2. For efficacy outcomes MADRS score, CGI-BP-S (total score, depression subscore and overall bipolar illness subscore), and Quality of life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) score were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 462 patients, out of which 276 in S1[Test=139; Comparator=137] and 186 in S2[Test=92; Comparator=94]. The baseline demographic characteristics were comparable in between treatment arms across subgroups. The primary endpoint of reduction in MADRS score from baseline to Day 42 in Test arm was non-inferior to Comparator arm in both subgroups [Figure 1] as the upper 95% CI was below the pre-defined margin of 3.0. The reduction of CGI-BP-S (total score, depression subscore and overall bipolar illness subscore) from Day 14 to Day 42 were comparable in both Test and Comparator arms in both subgroups. The improvement in Q-LES-Q-SF score from baseline to Day 42 were comparable in both Test and Comparator arms in both subgroups. The incidence of TEAEs were similar in both treatment arms [S1: Test=38.1% and Comparator=36.5%; S2: Test=29.3% and Comparator=34.0%] and no serious adverse events were reported.

Image 1:

This subgroup analysis demonstrated that Lumateperone 42mg is non-inferior to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, irrespective of baseline BMI and both treatments were found to be well tolerated. Hence, Lumateperone can be considered as valuable treatment option in management of Bipolar II depression.

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

Lumateperone, an atypical antipsychotic drug, has a dual mechanism of action by combination of activity at central serotonin (5-HT2A) and dopamine (D2) receptors.

This subgroup analysis of an Indian Phase 3 study was conducted to evaluate the efficacy and safety of Lumateperone 42mg compared to Quetiapine 300mg in treatment of Bipolar II depression when stratified based on prior hypomanic episodes.

The phase-III, randomized, multi-centric, assessor-blind, parallel-group, active-controlled, comparative, non-inferiority study included Indian 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. The patients were stratified based on number of prior hypomanic episodes in lifetime: Subgroup 1 [S1]: 1 episode and Subgroup 2 [S2]: >1 episode. For efficacy outcomes MADRS score, CGI-BP-S (total score, depression subscore and overall bipolar illness subscore), and Quality of life enjoyment and satisfaction-short form questionnaire (Q-LES-Q-SF) score were evaluated and for safety outcomes treatment emergent adverse events (TEAEs) were assessed. [Clinical trial registration: CTRI/2023/10/058583]

This subgroup analysis included 462 patients, out of which 251 in S1[Test=129; Comparator=122] and 211 in S2[Test=102; Comparator=109]. The baseline demographic characteristics were comparable in between treatment arms across subgroups. The primary endpoint of reduction in MADRS score from baseline to Day 42 in Test arm was non-inferior to Comparator arm in both subgroups [Figure 1] as the upper 95% CI was below the pre-defined margin of 3.0. The reduction of CGI-BP-S (total score, depression subscore and overall bipolar illness subscore) from Day 14 to Day 42 were comparable in both Test and Comparator arms in both subgroups. The improvement in Q-LES-Q-SF score from baseline to Day 42 were comparable in both Test and Comparator arms in both subgroups. The incidence of TEAEs were similar in both treatment arms [S1: Test=37.2% and Comparator=35.2%; S2: Test=31.4% and Comparator=35.8%] and no serious adverse events were reported.

Image 1:

This subgroup analysis demonstrated that Lumateperone 42mg is non-inferior to Quetiapine 300mg in treatment of Bipolar II depression as assessed via MADRS score from baseline to Day 42, irrespective of number of previous hypomanic episodes and both treatments were found to be well tolerated.

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.

Substance dependence affects an individual as well as the family and is considered as a complex biopsychosocial phenomenon. Family members can act as a social and emotional support in the treatment engagement and recovery of the patient with substance use disorder. Caregiving is a multidimensional construct. Caregiving process to an individual with substance use disorder can help in either positive or negative outcome and is often challenging. Positive aspects of caregiving has gathered some attention in mental health literature in recent past, data for the same is limited across substance use disorder.

To determine whether substance use status is associated with differences in positive aspects of caregiving and burden among the caregivers of patients with opioid use disorders.

A cross-sectional observational study with purposive sampling was used to recruit 199 caregivers of patients with opioid use disorders. The sample was divided based upon the current substance use status of the patients. Scale for Positive Aspects of Caregiving Experience (SPACE) and Family Burden Interview Schedule (FBIS) were used to assess positive aspects of caregiving and family burden respectively

The study included 199 caregivers of patients with opioid use disorder. Table 1 describes the socio-demographic profile of the patients and caregivers. Of 199 caregivers recruited, 135 (67.8%) reported that the patient was using opioids, while 64 (32.2%) reported that the patient was abstinent on treatment. The mean SPACE domain score of caregivers abstinent on treatment was highest for motivation for caregiving role (2.73 versus 1.76) followed by self-esteem and social aspect of caring (2.42 versus 1.87), caregiver satisfaction (2.41 versus 1.29) and caregiving personal gains (2.40 versus 1.45). Details of SPACE domain score and FBIS are depicted in table 2. It was seen that caregivers of patients currently abstinent on treatment experienced greater positive aspects of caregiving (SPACE mean score 128.3 versus 80.1, t = 9.383, p <0.001), and lesser burden (FBIS mean score 13.4 versus 29.3, t = 10.419, p <0.001). Overall the mean SPACE domain score had a negative correlation with FBIS (r = -0.57, p<0.001).

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Image 2:

In our study it was found that caregivers of patients who are currently abstinent on treatment experience lower burden of care, and also experience greater positive aspects of caregiving. Clinicians should be aware of the caregiver experiences as well as they engage both patients and caregivers in the treatment process.

Keywords: Positive Aspects of Caregiving Experience; Family Burden; Caregivers; Opioid; Substance.

None Declared