Poster
66
(#66) Efficacy of Aripiprazole Once-Monthly and Aripiprazole 2-Month Ready-To-Use on Insight in Schizophrenia: Post Hoc Analyses of Three Trials
Psych Congress 2025
Abstract: Introduction: Poor insight adversely affects prognosis in schizophrenia. These post hoc analyses assessed the efficacy of aripiprazole once-monthly (AOM) 400 mg (AOM 400) and aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) on insight in schizophrenia.
Methods: Data were from Study 246 (NCT00705783; AOM 400 vs placebo for 52 weeks after oral aripiprazole stabilization), Study 247 (NCT00706654; AOM 400 vs oral aripiprazole 10-30 mg/day vs AOM 50 mg [AOM 50] for 38 weeks after oral aripiprazole stabilization), and Study 181 (NCT04030143; AOM 400 vs Ari 2MRTU 960 for 32 weeks in stable patients). Insight was assessed using PANSS item G12 (lack of judgment and insight) scored from 1 (absent) to 7 (extreme). Analysis of Study 181 included patients with baseline G12 score >2 only.
Results: In Study 246 (n=403), mean baseline PANSS G12 score (2.40) improved after stabilization on oral aripiprazole (2.22); the improvement was maintained with AOM 400 at 52 weeks post-randomization, but not with placebo (2.17 vs 2.48; p=0.0031).
In Study 247 (n=662), mean baseline PANSS G12 score (2.36) improved after stabilization on oral aripiprazole (2.21); the improvement was maintained at Week 38 in those randomized to AOM 400 (2.11) or oral aripiprazole (2.22) but not AOM 50 (2.37; p=0.0019 vs AOM 400).
In Study 181 (n=185), the least-squares mean change in PANSS G12 score at Week 32 was -0.09 with AOM 400 (p=0.3714 vs baseline) and -0.25 with Ari 2MRTU 960 (p=0.0169 vs baseline).
Conclusions: AOM 400 and Ari 2MRTU 960 may improve insight in schizophrenia.
Short Description: Poor insight adversely affects prognosis in schizophrenia. These post hoc analyses assessed the efficacy of aripiprazole once-monthly 400 mg (AOM 400) and aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) on insight in schizophrenia, using PANSS item G12 (lack of judgment and insight) data from three clinical trials. Across the trials, improvements in insight were seen with aripiprazole treatment.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and Lundbeck LLC (Deerfield, IL, USA).
Methods: Data were from Study 246 (NCT00705783; AOM 400 vs placebo for 52 weeks after oral aripiprazole stabilization), Study 247 (NCT00706654; AOM 400 vs oral aripiprazole 10-30 mg/day vs AOM 50 mg [AOM 50] for 38 weeks after oral aripiprazole stabilization), and Study 181 (NCT04030143; AOM 400 vs Ari 2MRTU 960 for 32 weeks in stable patients). Insight was assessed using PANSS item G12 (lack of judgment and insight) scored from 1 (absent) to 7 (extreme). Analysis of Study 181 included patients with baseline G12 score >2 only.
Results: In Study 246 (n=403), mean baseline PANSS G12 score (2.40) improved after stabilization on oral aripiprazole (2.22); the improvement was maintained with AOM 400 at 52 weeks post-randomization, but not with placebo (2.17 vs 2.48; p=0.0031).
In Study 247 (n=662), mean baseline PANSS G12 score (2.36) improved after stabilization on oral aripiprazole (2.21); the improvement was maintained at Week 38 in those randomized to AOM 400 (2.11) or oral aripiprazole (2.22) but not AOM 50 (2.37; p=0.0019 vs AOM 400).
In Study 181 (n=185), the least-squares mean change in PANSS G12 score at Week 32 was -0.09 with AOM 400 (p=0.3714 vs baseline) and -0.25 with Ari 2MRTU 960 (p=0.0169 vs baseline).
Conclusions: AOM 400 and Ari 2MRTU 960 may improve insight in schizophrenia.
Short Description: Poor insight adversely affects prognosis in schizophrenia. These post hoc analyses assessed the efficacy of aripiprazole once-monthly 400 mg (AOM 400) and aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) on insight in schizophrenia, using PANSS item G12 (lack of judgment and insight) data from three clinical trials. Across the trials, improvements in insight were seen with aripiprazole treatment.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and Lundbeck LLC (Deerfield, IL, USA).
