Poster
52
(#52) Effect of long-term treatment with adjunctive cariprazine on anhedonia in patients with major depressive disorder: Post hoc analysis of a 26-week open-label study
Psych Congress 2025
Abstract: Background:Anhedonia is a core major depressive disorder(MDD) symptom.Cariprazine is an approved adjunctive therapy for MDD in adults. Short-term trials showed that cariprazine plus antidepressant therapy(ADT) improves anhedonia symptoms. This post hoc analysis evaluated the long-term effect of adjunctive cariprazine on anhedonia during a 26 week, open-label(OL), flexible-dose phase 3 safety study in MDD.
Methods:Patients with MDD and inadequate response to ADT completing an 8-week, phase 3 lead-in study or newly recruited into OL study were treated with flexible-dose cariprazine (1.5-4.5mg/day) plus ADT for 26 weeks. Anhedonia was assessed using the MADRS anhedonia subscale, comprised of 5 item scores.Outcomes included mean(SE) change at wk26 and end of the OL treatment (last available observation).Analyses were based on the intent-to-treat(ITT) population: ≥1 dose, baseline assessment, ≥1 postbaseline assessment.
Results: At baseline, the mean(SE) MADRS anhedonia subscale score was 13.71(0.31) (N=336). Cariprazine was associated with reductions from baseline in anhedonia subscale scores at all visits.Mean(SE) changes from baseline in anhedonia subscale score at wk26(n=210) and last available observation(N=336) were -6.73(0.45) and -5.42(0.37).Similarly, item scores decreased at all visits. Mean(SE) baseline for apparent sadness, reported sadness, concentration difficulties, lassitude, and inability to feel were 2.69(0.07), 2.93(0.07), 2.64(0.08), 2.69(0.07), and 2.76(0.07), respectively; at wk26(n=210), mean(SE) changes from baseline were -1.45(0.11), -1.48(0.11), -1.29(0.10), -1.13(0.11), and -1.38(0.12), respectively. Using last available observation(N=336), the mean(SE) changes from baseline on anhedonia-related items ranged from -0.93(0.09) to -1.23(0.09).
Conclusions:Long-term open-label adjunctive cariprazine treatment improved anhedonia for up to 26 weeks.Previous safety findings suggest that long-term treatment is safe and well tolerated.
Short Description: This poster presents a post hoc analysis of cariprazine's long-term efficacy on anhedonia in major depressive disorder (MDD) within a 26-week open-label study. The findings demonstrate significant and sustained reductions in anhedonia scores. These results suggest that cariprazine is a well-tolerated adjunctive treatment, offering substantial improvements in anhedonia, a core MDD symptom, over an 26 wk extended treatment duration.
Name of Sponsoring Organization(s): AbbVie
Methods:Patients with MDD and inadequate response to ADT completing an 8-week, phase 3 lead-in study or newly recruited into OL study were treated with flexible-dose cariprazine (1.5-4.5mg/day) plus ADT for 26 weeks. Anhedonia was assessed using the MADRS anhedonia subscale, comprised of 5 item scores.Outcomes included mean(SE) change at wk26 and end of the OL treatment (last available observation).Analyses were based on the intent-to-treat(ITT) population: ≥1 dose, baseline assessment, ≥1 postbaseline assessment.
Results: At baseline, the mean(SE) MADRS anhedonia subscale score was 13.71(0.31) (N=336). Cariprazine was associated with reductions from baseline in anhedonia subscale scores at all visits.Mean(SE) changes from baseline in anhedonia subscale score at wk26(n=210) and last available observation(N=336) were -6.73(0.45) and -5.42(0.37).Similarly, item scores decreased at all visits. Mean(SE) baseline for apparent sadness, reported sadness, concentration difficulties, lassitude, and inability to feel were 2.69(0.07), 2.93(0.07), 2.64(0.08), 2.69(0.07), and 2.76(0.07), respectively; at wk26(n=210), mean(SE) changes from baseline were -1.45(0.11), -1.48(0.11), -1.29(0.10), -1.13(0.11), and -1.38(0.12), respectively. Using last available observation(N=336), the mean(SE) changes from baseline on anhedonia-related items ranged from -0.93(0.09) to -1.23(0.09).
Conclusions:Long-term open-label adjunctive cariprazine treatment improved anhedonia for up to 26 weeks.Previous safety findings suggest that long-term treatment is safe and well tolerated.
Short Description: This poster presents a post hoc analysis of cariprazine's long-term efficacy on anhedonia in major depressive disorder (MDD) within a 26-week open-label study. The findings demonstrate significant and sustained reductions in anhedonia scores. These results suggest that cariprazine is a well-tolerated adjunctive treatment, offering substantial improvements in anhedonia, a core MDD symptom, over an 26 wk extended treatment duration.
Name of Sponsoring Organization(s): AbbVie
