Purpose: This subgroup analysis examined the effect of PP1M as monotherapy or in combination with antidepressants (AD) or mood stabilizers (MS) on active depressive and psychotic episodes in patients with SCA. Methods: In this multiphase study (NCT01193153), subjects with psychotic and mood symptoms received PP1M during an open-label (OL) 13-week, flexible-dose, lead-in period. Those who met stabilization criteria (PANSS ≤70 plus YMRS ≤12 plus HAM-D-21 ≤12) continued in a 12-week, fixed-dose, stabilization phase. The following were assessed: safety/tolerability, proportion of subjects with a ≥4-point reduction in HAM-D-21 score, proportion stabilized, and proportion meeting remission criteria (HAM-D-21 ≤7 plus YMRS ≤7 plus PANSS ≤60) at the end of the lead-in period. Results: 667 subjects enrolled. This analysis focused on those with a screening episode of depression and psychosis (n=320; 48%). Of these 320 subjects, 148 received PP1M monotherapy and 172 received PP1M in combination with AD/MS. At the end of the lead-in period, 84.4% and 81.8% of subjects in those groups, respectively, had a ≥4-point reduction in HAM-D-21 score, 63.3% and 65.9% met stabilization criteria, and 13.6% and 12.4% met remission criteria. Most common adverse events reported during the 25-week treatment in the monotherapy and adjunctive groups, respectively: injection site pain (11.5%, 8.1%), weight increased (7.4%, 8.7%), akathisia (13.5%, 9.9%), and insomnia (8.8%, 8.7%). Conclusion: In this OL single-arm study phase, PP1M as monotherapy or with AD/MS demonstrated efficacy for controlling depressive, manic, and psychotic symptoms in SCA patients with active episodes of depression and psychosis.
DJ Fu, MD, PhD
Cynthia Bossie, PhD
Ibrahim Turkoz, PhD
Edward Kim, MD, MBA
Janssen Scientific Affairs, LLC