Effects on Satisfaction and Service Engagement of Paliperidone Palmitate Compared with Oral Paliperidone in Patients with Schizophrenia: An Open Label Randomized Controlled Trial
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Background and Objective
Clinical practice guidelines recommend antipsychotic monotherapy, including oral and long-acting formulations, in the treatment of schizophrenia. This open-label, randomized, controlled trial aimed to evaluate the efficacy and tolerability in patients with schizophrenia of once-monthly long-acting paliperidone palmitate (PP1M) compared with oral paliperidone extended release (ER), with a particular focus on satisfaction, subjective well-being, and service engagement.
Seventy-two consecutive outpatients with schizophrenia (DSM-5) were randomly assigned for 6 months to: (1) PP1M (50–150 mg equivalent) or (2) paliperidone ER (6–12 mg/day). Participants were assessed at baseline and after 6 months with the Treatment Satisfaction Questionnaire for Medication (TSQM); the Subjective Well-being under Neuroleptics Scale (SWN-K); the Service Engagement Scale (SES); the Clinical Global Impression–Schizophrenia (CGI–SCH); and the Personal and Social Performance (PSP) score. ANOVA repeated measures was performed. Intention-to-treat analysis with last observation carried forward was conducted.
We found a significant within-subjects effect (trial duration) for all rating scale except for cognitive symptoms and the TSQM domain “side effects”. A significant effect between subjects (treatment modality) was found for the CGI negative symptoms, the TSQM domains “overall satisfaction” and “convenience,” and the SES. There were seven drop-outs (9.7%): twi due to hyperprolactinemia and five for lack of compliance.
Significant differences between the two formulations were found. PP1M was superior to paliperidone ER on global treatment satisfaction and convenience, on service engagement, and in reducing negative symptoms.
The trial was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the code: ACTRN12618001113246.
Compliance with Ethical Standards
This study was supported by Ministero dell’Istruzione, dell’Università e della Ricerca - MIUR projects “Dipartimenti di Eccellenza 2018-2022” of the Department of Neuroscience “Rita Levi Montalcini”.
Conflict of interest
The authors declare that they have no conflicts of interest.
Informed consent and ethics approval
Each patient participated voluntarily in the study after providing written informed consent. Declaration of Helsinki guidelines (1964) were followed. Ethical approval was obtained from the ethics committee of A.O.U. “Città della Salute e della Scienza-A.O. Ordine Mauriziano-A.S.L.” of Turin.
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