Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin
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Symptoms of schizophrenia fall into three categories (positive, negative and cognitive symptoms), which probably impact differently on patient’s health-related quality of life (HRQoL). The present study aimed to explore HRQoL in patients with prominent negative symptoms.
In the 323 patients with prominent negative symptoms included in a multicenter Phase II trial investigating the safety and efficacy of bitopertin, HRQoL was assessed using the Schizophrenia Quality of Life Scale (SQLS), symptoms severity using the Positive and Negative Syndrome Scale and functioning using the Personal and Social Performance Scale. SQLS measurement properties were assessed; HRQoL was compared between treatment arms, and relationships between HRQoL, symptoms and functioning at baseline were explored.
Both SQLS scores (Vitality/Cognition and Psychosocial Feelings) demonstrated good test–retest (ICC = 0.77 and 0.74) and internal consistency reliability (Cronbach’s α = 0.86 and 0.93). Clinical validity with regard to schizophrenia severity and ability to detect change in severity of symptoms of schizophrenia were satisfactory. The SQLS structure was not formally disconfirmed. No statistically significant difference was observed between treatment arms. Negative symptoms were more strongly associated with functioning than positive symptoms. Functioning and Anxiety/Depression were strongly related to both SQLS domains.
Overall, SQLS measurement properties were supported in these patients with prominent negative symptoms of schizophrenia. The impact of negative symptoms on functioning and HRQoL suggests that improving these symptoms will be a meaningful benefit in this population of patients.
KeywordsQuality of life Schizophrenia Negative symptoms Bitopertin
The authors would like to thank Fatoumata Fofana (Mapi) for support with the statistical analysis, and Jérémy Lambert (Mapi) for medical writing assistance and editorial support in manuscript preparation. J&J agree and acknowledge that OXFORD OUTCOMES exclusively owns all intellectual and other property rights, including all worldwide copyrights to the SQLS and revisions to it for perpetuity. From 2003, OXFORD OUTCOMES is permitted to consent to the use of the SQLS or revisions of it by any person or entity subject to them signing the user’s agreement without the permission or knowledge of J&J.
Compliance with Ethical Standards
This study was funded by Hoffmann-La Roche.
Conflict of interest
DR and SS are employees of Roche Products LTD, and CGB and DU are employees of F Hoffmann-La Roche. AR, employee of Mapi, was paid consultant to Roche Products LTD. RF was paid consultant to Roche Products LTD.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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