A Randomized Double‐Blind Active‐Controlled Study of the Safety of UP165 and its Effects on Assessments of Depression, Anxiety and Well Being

This clinical trial compared the safety and effects of UP165, a dietary supplement that may be linked to mood function, with SAM‐e (s‐adenosylmethionine), a popular mood enhancing supplement. Assessments were made using the Beck Depression Inventory (BDI‐II), the Beck Anxiety Inventory (BAI), Schwartz Outcome Scale (SOS‐10) and Arizona Sexual Experiences Scale (ASEX). Forty‐two subjects (21–65 yo) were randomized to eight‐weeks of supplementation with UP165 or SAM‐e with questionnaires being administered at screening/randomization and weeks 4 and 8 of supplementation. Thirty‐four subjects were included in the efficacy analysis. There were no safety concerns raised by this study. UP165 and SAM‐e produced improvements in scores on the four questionnaires although no statistically significant differences were observed. UP165 was shown to be non‐inferior to SAM‐e with respect to depression (not within the ±8.35 equivalence tolerance interval) and equivalent to SAM‐e with respect to anxiety (fell within the ±6.4 equivalence tolerance interval). No superiority was noted between products. Future studies should examine increases in dose and or duration. A randomized double blind placebo‐controlled trial could strengthen the findings. Funded by a grant from: Unigen Pharmaceuticals