Abstracts
3427200
(#19) Remission With Lumateperone 42 mg Adjunctive to Antidepressant Therapy in Patients With Major Depressive Disorder: Analysis of Short-Term and Long-Term Trials
Abstract: Background: Lumateperone is an atypical antipsychotic to treat schizophrenia, depressive episodes associated with bipolar I or II disorder, and major depressive disorder (MDD). This analysis of two Phase 3, randomized, double-blind, placebo-controlled studies (Study 501 [NCT04985942]; Study 502 [NCT05061706]) and open-label extension study (OLE; Study 503 [NCT05061719]) evaluated Montgomery-Asberg Depression Rating Scale (MADRS) Total score remission rates in patients with MDD with inadequate antidepressant therapy (ADT) response.
Methods: Studies 501/502 randomized (1:1) patients with DSM-5 criteria for MDD with inadequate response to 1-2 ADTs in the current depressive episode to 6-week placebo+ADT or lumateperone 42mg+ADT. Those completing double-blind treatment could enroll in Study 503 to receive 26-week lumateperone 42mg+ADT. MADRS remission, complete remission, and sustained remission (MADRS Total score ≤10, ≤5, and ≤10, respectively) were assessed.
Results: The modified intent-to-treat population comprised 950 patients (lumateperone+ADT, n=471; placebo+ADT, n=479) in 501/502; 809 enrolled in 503.
There were significantly greater MADRS remission rates at Day 43 with lumateperone+ADT vs placebo+ADT in the pooled 501/502 analysis (25.5% vs 13.6%; P.0001), and significantly greater complete remission (10.6% vs 5.6%; P.01) and sustained remission rates from Day 22 (6.2% vs 2.9%; P.05) to Day 43 (25.5% vs 13.6%; P.0001).
In 503, lumateperone+ADT resulted in high MADRS remission rates in 529 (65.4%) patients at end of OLE. Complete remission was achieved by 44.1% of patients by end of open-label treatment, with sustained remission rates reaching 60.4% by Week 26.
Conclusion: Two-thirds of patients achieved remission with 6-month adjunctive lumateperone treatment, supporting lumateperone as adjunctive therapy.
Short Description: Montgomery-Asberg Depression Rating Scale (MADRS) Total score remission rates with lumateperone 42mg adjunctive to antidepressant therapy (ADT) were evaluated in Phase 3, randomized, double-blind 501/502 trials and open-label extension study 503 in patients with MDD. Lumateperone+ADT showed significantly greater MADRS remission rates at Day 43 vs placebo+ADT, higher complete and sustained remission from Day 22 to 43 (501/502), and high MADRS remission rates and improved complete and sustained remission by Week 26 (503).
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
Methods: Studies 501/502 randomized (1:1) patients with DSM-5 criteria for MDD with inadequate response to 1-2 ADTs in the current depressive episode to 6-week placebo+ADT or lumateperone 42mg+ADT. Those completing double-blind treatment could enroll in Study 503 to receive 26-week lumateperone 42mg+ADT. MADRS remission, complete remission, and sustained remission (MADRS Total score ≤10, ≤5, and ≤10, respectively) were assessed.
Results: The modified intent-to-treat population comprised 950 patients (lumateperone+ADT, n=471; placebo+ADT, n=479) in 501/502; 809 enrolled in 503.
There were significantly greater MADRS remission rates at Day 43 with lumateperone+ADT vs placebo+ADT in the pooled 501/502 analysis (25.5% vs 13.6%; P.0001), and significantly greater complete remission (10.6% vs 5.6%; P.01) and sustained remission rates from Day 22 (6.2% vs 2.9%; P.05) to Day 43 (25.5% vs 13.6%; P.0001).
In 503, lumateperone+ADT resulted in high MADRS remission rates in 529 (65.4%) patients at end of OLE. Complete remission was achieved by 44.1% of patients by end of open-label treatment, with sustained remission rates reaching 60.4% by Week 26.
Conclusion: Two-thirds of patients achieved remission with 6-month adjunctive lumateperone treatment, supporting lumateperone as adjunctive therapy.
Short Description: Montgomery-Asberg Depression Rating Scale (MADRS) Total score remission rates with lumateperone 42mg adjunctive to antidepressant therapy (ADT) were evaluated in Phase 3, randomized, double-blind 501/502 trials and open-label extension study 503 in patients with MDD. Lumateperone+ADT showed significantly greater MADRS remission rates at Day 43 vs placebo+ADT, higher complete and sustained remission from Day 22 to 43 (501/502), and high MADRS remission rates and improved complete and sustained remission by Week 26 (503).
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
