| Popis: |
Background: More rapidly acting antidepressants are needed for individuals with major depressive disorder (MDD). A new class of neuroactive steroids called pherines have shown rapid and potent effects when administered intranasally. A study of pherine PH10 was conducted in subjects with MDD. Methods: Thirty subjects with MDD were randomized to 8 weeks of self‐administered intranasal PH10 low dose (3.2mg), PH10 high dose (6.4mg), or placebo. Changes on the Hamilton 17‐item depression rating scale (HAM‐D‐17) were compared. Results: Overall comparison of HAM‐D‐17 endpoint scores for the three treatment groups showed a trend for difference (p = 0.07). Pairwise comparisons showed a greater reduction in HAM‐D‐17 scores for high dose PH10 (p = 0.022) and a trend for low dose PH10 (p = 0.101) compared to treatment with placebo. There were strong effect sizes for both active treatment groups versus placebo at study endpoint, as well as after one week of treatment. Treatments were well tolerated and there were no Serious Adverse Events. Conclusions: Results from this small trial must be considered tentative. Findings suggest that PH10 could represent a useful treatment for MDD with a rapid onset of efficacy, and continue to validate the nasal chemosensory neural circuits as a novel mechanism of action of pherines. |
