BrainCells reports BCI-952 data

BrainCells Inc. (San Diego, Calif.) reported mixed results from a Phase II trial of BCI-952 to treat major depressive disorder (MDD). A modified intent-to-treat (ITT) analysis showed the combination of low-dose buspirone and melatonin met the co-primary endpoint of mean Clinical Global Impression-Improvement (CGI-I) score at week six (p=0.046 vs. placebo), but missed the other co-primary endpoint of Quick Inventory of Depressive Symptomatology Self-Reported (QIDS SR16) score. The modified ITT analysis used a mixed model repeated measure (MMRM) that predicted dropouts' final scores rather than considering them to be failures. Results from an ITT analysis were not included in the company's announcement. ...