Personal and Social Functioning and Health-Related Quality of Life in Patients with Schizophrenia Treated with the Long-Acting Injectable Antipsychotic Risperidone ISM

Robert Litman; Dieter Naber; Lourdes Anta; Javier Martínez; Yuriy Filts; Christoph U Correll

doi:10.2147/NDT.S392351

Personal and Social Functioning and Health-Related Quality of Life in Patients with Schizophrenia Treated with the Long-Acting Injectable Antipsychotic Risperidone ISM

Neuropsychiatr Dis Treat. 2023 Jan 25:19:219-232. doi: 10.2147/NDT.S392351. eCollection 2023.

Authors

Robert Litman^{1

2}, Dieter Naber³, Lourdes Anta⁴, Javier Martínez⁴, Yuriy Filts⁵, Christoph U Correll^{6

7

8}

Affiliations

¹ CBH Health LLC, Gaithersburg, MD, USA.
² Department of Psychiatry, Georgetown University Medical School, Washington, DC, USA.
³ Department of Psychiatry and Psychotherapy, Hamburg-Eppendorf University, Hamburg, Germany.
⁴ Medical Department, Laboratorios Farmacéuticos ROVI, S.A., Madrid, Spain.
⁵ Communal Noncommercial Enterprise of Lviv Regional Council, Lviv Regional Clinical Psychiatric Hospital, Lviv, Ukraine.
⁶ Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA.
⁷ Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
⁸ Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany.

Abstract

Objective: To analyze the effect of Risperidone ISM on social functioning and health-related quality of life (HR-QoL) in both short- and long-term treatment of patients with schizophrenia.

Patients and methods: This analysis was based on data from both phases of the PRISMA-3 study, including 433 relapsed patients from the double-blind (DB) phase of the PRISMA-3 trial who were treated for 12-weeks with once-monthly (every 28 days) intramuscular Risperidone ISM 75 mg or 100 mg (n = 288), or placebo (n = 145), as well as 174 patients transitioning from the DB to an open-label 52-week extension (OLE) phase, plus 41 de novo patients treated on a stable maintenance dose of oral risperidone. The clinician-administered Personal and Social Performance (PSP) scale and the patient-reported 20-item Subjective Well-being under Neuroleptics scale (SWN-20) were used to measure social functioning and HR-QoL outcomes, respectively.

Results: Risperidone ISM significantly improved PSP total score from baseline to endpoint (Day 85) versus placebo in the DB phase with mean change total score (95% CI) of 10.7 (9; 12) compared to 4.8 (3; 7) for placebo (p < 0.0001). The statistically significant improvement was present from the first measurement time point (Day 29). SWN-20-measured HR-QoL increased on average in patients treated with Risperidone ISM in the DB phase. A significant improvement was also observed for PSP and SWN-20 scores from the OLE baseline to week 52 for patients transitioning from the DB phase. Stable de novo patients maintained similar PSP and SWN-20 scores during the whole OLE phase.

Conclusion: Risperidone ISM provided a rapid and sustained improvement in personal and social functioning, and HR-QOL without need of oral risperidone supplementation or loading doses. These findings, along with a fast onset of efficacy, could contribute to reinforcing the therapeutic alliance and possibly an earlier discharge. Moreover, patient functioning continued improving or was maintained with long-term treatment.

Keywords: antipsychotics; long-acting injectable; quality of life; risperidone; schizophrenia; social functioning.

Grants and funding

This study was funded by Laboratorios Farmacéuticos Rovi, S.A. Madrid, Spain. It was supported also in part by Centro para el Desarrollo Tecnológico Industrial (Expedient No. IDI-20160109).