Poster Explores Safety, Efficacy of Seltorexant for MDD, Insomnia

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CONFERENCE REPORTER

A poster at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting discussed a phase 3 clinical trial investigating the efficacy of seltorexant for the treatment of depressive symptoms in individuals with major depressive disorder (MDD) and insomnia.¹

The trial (NCT04533529²) evaluated the safety and effectiveness of seltorexant, a potent and selective orexin-2 receptor antagonist, in comparison with a placebo. Participants in the study were adults aged 18 to 74 years who had all been diagnosed with MDD without psychotic features. These individuals had shown inadequate responses to either selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) during their current depressive episodes.¹

The double-blind, placebo-controlled study spanned 6 weeks and involved 588 participants who were randomized to receive either seltorexant (20 mg) or a matching placebo. Both groups continued their baseline SSRI or SNRI treatment. The primary measure of efficacy was the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from the start of the study through day 43. Secondary measures included the MADRS without sleep item (MADRS-WOSI) total score and the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) T-score.¹

Results indicated that seltorexant significantly outperformed the placebo in reducing depressive symptoms by day 43. The least squares mean difference in MADRS total score between the seltorexant group and the placebo group was -2.6, with a p-value of 0.007, indicating statistical significance. Improvements were also noted in the key secondary endpoints: the MADRS-WOSI total score (difference of -2.0, p=0.023) and the PROMIS-SD T-score (difference of -3.7, p<0.001).¹

The safety analysis revealed that treatment-emergent adverse events were slightly more common in the placebo group (40.3%) compared with the seltorexant group (36.0%). Discontinuation rates due to treatment-emergent adverse events were low and similar between both groups (2.1% for seltorexant and 2.3% for placebo). Serious treatment-emergent adverse events occurred in 1participant from each group, although none were attributed to the study drug.¹

The study investigators concluded that seltorexant provides statistically significant and clinically meaningful improvements in depressive symptoms, beyond just alleviating insomnia, in patients with MDD. The drug’s safety profile was comparable to that of the placebo, suggesting that it is well-tolerated. These findings support further exploration and potential approval of seltorexant as an adjunctive treatment for depression, particularly for individuals who do not fully respond to traditional antidepressants.¹

The poster was presented by study co-author Michael E. Thase, MD, a professor of psychiatry at Perelman School of Medicine, University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center.

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Note: This article was prepared with the assistance of ChatGPT.

References

1. Thase ME, Krystal AD, Wajs, et al. Seltorexant, adjunctive to antidepressants, in adults with MDD with insomnia symptoms: results of a double-blind, randomized, placebo-controlled study. American Society of Clinical Psychopharmacology Annual Meeting. Poster presentation. May 29, 2024. Accessed May 29, 2024.

2. A study of seltorexant as adjunctive therapy to antidepressants in adult and elderly participants with major depressive disorder with insomnia symptoms who have responded inadequately to antidepressant and long-term safety extension treatment with seltorexant. Last updated May 24, 2024. Accessed May 29, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04533529