Abstracts
3427199
(#21) First Onset and Duration of Treatment-Emergent Adverse Events in Patients With Major Depressive Disorder Treated With Adjunctive Lumateperone 42 mg: A Pooled Analysis of 2 Randomized Placebo-Controlled Trials
Abstract: Background: Lumateperone is an atypical antipsychotic indicated to treat schizophrenia and bipolar depression, and as adjunctive to antidepressant therapy (ADT) for major depressive disorder (MDD). This pooled analysis of 2 positive Phase 3, randomized, double-blind, placebo-controlled studies (NCT04985942; NCT05061706) assessed first onset and duration of treatment-emergent adverse events (TEAEs) with lumateperone 42mg+ADT in patients with MDD with inadequate ADT response.
Methods: Data were pooled from 2 studies that enrolled adults with DSM-5-diagnosed MDD with inadequate response to 1-2 ADTs in the current depressive episode, Montgomery-Asberg Depression Rating Scale Total score ≥24, Clinical Global Impression-Severity Scale score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16 item score ≥14. Patients were randomized 1:1 to 6-week lumateperone 42mg+ADT or placebo+ADT. First onset and duration of TEAEs were evaluated descriptively.
Results: Of 964 patients treated (lumateperone+ADT, n=483; placebo+ADT, n=481), TEAEs occurred in 68.1% (lumateperone+ADT) and 45.1% (placebo+ADT). Common TEAEs (≥5%; twice placebo+ADT) were dizziness, dry mouth, somnolence, nausea, fatigue, and diarrhea. With lumateperone+ADT, TEAE onset occurred at ≤1 week in 45.3% of patients, >3 to ≤4 weeks in 4.1%, and >5 weeks in 2.1%. Mean durations of common TEAEs for lumateperone+ADT vs placebo+ADT weredizziness (9.5 vs 7.7 days), dry mouth (22.8 vs 17.3), somnolence (14.6 vs 14.9) nausea (7.2 vs 11.0) fatigue (20.7 vs 11.8), and diarrhea (7.3 vs 12.2).
Conclusion: In this pooled analysis, the most common TEAEs occurred early during treatment and resolved within approximately 1-3 weeks, supporting the safety and tolerability of lumateperone+ADT in patients with MDD with inadequate ADT response.
Short Description: In this pooled analysis of 2 Phase 3, randomized, double-blind, placebo-controlled studies (NCT04985942; NCT05061706), TEAEs occurred in 68.1% and 45.1% of the lumateperone 42mg+ADT and placebo+ADT groups, respectively. Common TEAEs included dizziness, dry mouth, somnolence, nausea, fatigue, and diarrhea. With lumateperone+ADT, rates of first TEAE onset decreased over time after Week 1, and the common TEAEs resolved within approximately 1-3 weeks. These findings support lumateperone as a well-tolerated adjunctive treatment option in patients with MDD.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
Methods: Data were pooled from 2 studies that enrolled adults with DSM-5-diagnosed MDD with inadequate response to 1-2 ADTs in the current depressive episode, Montgomery-Asberg Depression Rating Scale Total score ≥24, Clinical Global Impression-Severity Scale score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16 item score ≥14. Patients were randomized 1:1 to 6-week lumateperone 42mg+ADT or placebo+ADT. First onset and duration of TEAEs were evaluated descriptively.
Results: Of 964 patients treated (lumateperone+ADT, n=483; placebo+ADT, n=481), TEAEs occurred in 68.1% (lumateperone+ADT) and 45.1% (placebo+ADT). Common TEAEs (≥5%; twice placebo+ADT) were dizziness, dry mouth, somnolence, nausea, fatigue, and diarrhea. With lumateperone+ADT, TEAE onset occurred at ≤1 week in 45.3% of patients, >3 to ≤4 weeks in 4.1%, and >5 weeks in 2.1%. Mean durations of common TEAEs for lumateperone+ADT vs placebo+ADT weredizziness (9.5 vs 7.7 days), dry mouth (22.8 vs 17.3), somnolence (14.6 vs 14.9) nausea (7.2 vs 11.0) fatigue (20.7 vs 11.8), and diarrhea (7.3 vs 12.2).
Conclusion: In this pooled analysis, the most common TEAEs occurred early during treatment and resolved within approximately 1-3 weeks, supporting the safety and tolerability of lumateperone+ADT in patients with MDD with inadequate ADT response.
Short Description: In this pooled analysis of 2 Phase 3, randomized, double-blind, placebo-controlled studies (NCT04985942; NCT05061706), TEAEs occurred in 68.1% and 45.1% of the lumateperone 42mg+ADT and placebo+ADT groups, respectively. Common TEAEs included dizziness, dry mouth, somnolence, nausea, fatigue, and diarrhea. With lumateperone+ADT, rates of first TEAE onset decreased over time after Week 1, and the common TEAEs resolved within approximately 1-3 weeks. These findings support lumateperone as a well-tolerated adjunctive treatment option in patients with MDD.
Name of Sponsoring Organization(s): Intra-Cellular Therapies, a Johnson & Johnson company
