The trial met the primary and secondary endpoints with statistically significant placebo-adjusted improvements at Week 3 in the YMRS total score (3.1 points; p=0.045) and CGI-BP Severity of Mania score (0.4 points; p=0.024)
RAP-219–treated patients had a 15.4-point mean reduction in YMRS total score from baseline at Week 3
All 11 items measured by the YMRS improved numerically compared to placebo at Week 3, with improvements in irritability, thought content, disruptive-aggressive behavior, and sexual interest reaching nominal significance
RAP-219 was well tolerated; all treatment-emergent adverse events during the treatment period were mild or moderate
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