An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Abstract

Objectives: To evaluate clinical evolution of patients with schizophrenia admitted in acute units because of a relapse and treated with once-monthly Paliperidone Palmitate (PP1M).

Methods: This multicentre, open-label, prospective observational study followed patients with schizophrenia treated with PP1M in acute psychiatric units for up to 6 weeks.

Results: Out of the 280 enrolled patients, 61 received PP1M as antipsychotic monotherapy, and 219 in combination with other antipsychotics. The average Clinical Global Impression–Schizophrenia (CGI-SCH) score decreased from 4.7 at baseline to 3.3 at final visit (p < .0001); the change was clinically and statistically significant both in patients treated with PP1M in monotherapy and in combination with other antipsychotics. Clear improvements in functioning and high patient satisfaction with the treatment were observed. Time from admission to PP1M therapy initiation correlated with the length of hospital stay (p < .0001); earlier start of PP1M treatment was associated with shorter hospital stay. Adverse events were reported in 7.1% of patients (all non-serious).

Conclusions: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

Keywords:

• Schizophrenia
• atypical antipsychotics
• Paliperidone Palmitate
• acute schizophrenia episodes
• long-acting treatments
• injectable antipsychotics

Acknowledgements

We would like to thank all the centres and investigators who participated in this study.

Hospital Clínic – Dr. Eduard Parellada and Dr. Miquel Bioque; Sagrat Cor de Martorel – Dr. Antonio Arévalo Sánchez; Mutua Terrassa – Dr. Jose Gascón Barrachina; Hospital Universitario Donostia – Dr. Marta Alonso; Hospital Universitario De Araba – Dr. Mahmond Karim Haidar; Hospital Galdakao – Dr. José Martín Zurimendi; Hospital Cruces – Dr. Jon García Ormaza; Hospital Clínico Universitario Salamanca – Dr. Juan Matías Fernández; Hospital Clínico Universitario Valladolid – Dr. Jose Antonio Blanco Garrote; Complejo Asistencial Universitario de Burgos – Dr. Avelino de Dios Francos; Hospital Virgen del Mirón – Dr. Ricardo Martínez Gallardo; Hospital de Conxo – Dr. Mario Páramo; Hospital de Oza, La Coruña – Dr. Manuel Serrano; Hospital Arquitecto Marcide – Dr. Jose Manuel Crespo; Hospital Marqués de Valdecilla – Dr. JesusArtal Simón; Hospital Sant Joan de Deu Llobregat – Dr. Antonio Serrano Blanco; Hospital Universitario De Basurto – Dr. Sonia Bustamante Madariaga; Hospital Sant Joan de Deu Manresa – Dr. Pere Bonet; Hospital de Mataró – Dr. Josep Cañete; Hospital de Pontevedra – Dr. Isauro Gómez; Hospital Vall D´Hebrón – Dr. Jose Antonio Ramos-Quiroga.

Disclosure statement

Parellada has received honoraria and/or research grants from the Fondo de Investigación Sanitaria of the Spanish Ministry of Science and Innovation, Fundació la Marató de TV3 of Catalonia, Janssen-Cilag, Glaxo-Smith-Kline and Ferrer. Bioque has been a consultant for, received grants/research support and honoraria from, and been on the speakers/advisory board of Adamed, Ferrer, Janssen-Cilag, Lundbeck, Otsuka, and Pfizer. Serrano has been a consultant for, received grants/research support and honoraria from, and been on the speakers/advisory board of Janssen-Cilag and Otsuka. Medical writing support was provided by CONTENT ED NET COMMUNICATIONS, S.L. and funded by Janssen-Cilag.