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05-07-2015 | Uitgave 1/2016

Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin

Tijdschrift:: Quality of Life Research > Uitgave 1/2016

Auteurs:: Diana Rofail, Antoine Regnault, Stéphanie le Scouiller, Carmen Galani Berardo, Daniel Umbricht, Ray Fitzpatrick

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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

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Meer informatie

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. (2009). Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

McCabe, R., Saidi, M., & Priebe, S. (2007). Patient-reported outcomes in schizophrenia. British Journal of Psychiatry. Supplement,50, s21–s28. CrossRef

Gee, L., Pearce, E., & Jackson, M. (2003). Quality of life in schizophrenia: A grounded theory approach. Health and Quality of Life Outcomes,1, 31. PubMedPubMedCentralCrossRef

van Os, J., & Kapur, S. (2009). Schizophrenia. Lancet,374(9690), 635–645. PubMedCrossRef

Folsom, D. P., Depp, C., Palmer, B. W., Mausbach, B. T., Golshan, S., Fellows, I., et al. (2009). Physical and mental health-related quality of life among older people with schizophrenia. Schizophrenia Research,108(1–3), 207–213. PubMedPubMedCentralCrossRef

Wilkinson, G., Hesdon, B., Wild, D., Cookson, R., Farina, C., Sharma, V., et al. (2000). Self-report quality of life measure for people with schizophrenia: The SQLS. British Journal of Psychiatry,177(42–6), 42–46. PubMedCrossRef

Rouillon, F., Eriksson, L., Burba, B., Raboch, J., Kaprinis, G., & Schreiner, A. (2013). Functional recovery results from the risperidone long-acting injectable versus quetiapine relapse prevention trial (ConstaTRE). Acta Neuropsychiatrica,25(5), 297–306. PubMedCrossRef

Mortimer, A. M., & Al-Agib, A. O. (2007). Quality of life in schizophrenia on conventional versus atypical antipsychotic medication: A comparative cross-sectional study. International Journal of Social Psychiatry,53(2), 99–107. PubMedCrossRef

Shirazi-Southall, S., Rodriguez, D. E., & Nomikos, G. G. (2002). Effects of typical and atypical antipsychotics and receptor selective compounds on acetylcholine efflux in the hippocampus of the rat. Neuropsychopharmacology,26(5), 583–594. PubMedCrossRef

10.

Hill, S. K., Bishop, J. R., Palumbo, D., & Sweeney, J. A. (2010). Effect of second-generation antipsychotics on cognition: Current issues and future challenges. Expert Review of Neurotherapeutics,10(1), 43–57. PubMedPubMedCentralCrossRef

11.

Leucht, S., Corves, C., Arbter, D., Engel, R. R., Li, C., & Davis, J. M. (2009). Second-generation versus first-generation antipsychotic drugs for schizophrenia: A meta-analysis. Lancet,373(9657), 31–41. PubMedCrossRef

12.

Tandon, R., Nasrallah, H. A., & Keshavan, M. S. (2010). Schizophrenia, “just the facts” 5. Treatment and prevention. Past, present, and future. Schizophrenia Research,122(1–3), 1–23. PubMedCrossRef

13.

Malhotra, A. K., Pinals, D. A., Weingartner, H., Sirocco, K., Missar, C. D., Pickar, D., et al. (1996). NMDA receptor function and human cognition: The effects of ketamine in healthy volunteers. Neuropsychopharmacology,14(5), 301–307. PubMedCrossRef

14.

Noetzel, M. J., Jones, C. K., & Conn, P. J. (2012). Emerging approaches for treatment of schizophrenia: Modulation of glutamatergic signaling. Discovery of Medicine,14(78), 335–343.

15.

Pinard, E., Alanine, A., Alberati, D., Bender, M., Borroni, E., Bourdeaux, P., et al. (2010). Selective GlyT1 inhibitors: discovery of [4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl][5-methanesulfonyl-2-((S)-2,2,2-trifluoro-1-methylethoxy)phenyl]methanone (RG1678), a promising novel medicine to treat schizophrenia. Journal of Medicinal Chemistry,53(12), 4603–4614. PubMedCrossRef

16.

Umbricht, D., Alberati, D., Martin-Facklam, M., Borroni, E., Youssef, E. A., Ostland, M., et al. (2014). Effect of bitopertin, a glycine reuptake inhibitor, on negative symptoms of schizophrenia: A randomized, double-blind, proof-of-concept study. JAMA Psychiatry,71(6), 637–646. PubMedCrossRef

17.

Marder, S. R., Davis, J. M., & Chouinard, G. (1997). The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: Combined results of the North American trials. Journal of Clinical Psychiatry,58(12), 538–546. PubMedCrossRef

18.

Martin, C. R., & Allan, R. (2007). Factor structure of the Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4). Psychology, Health and Medicine,12(2), 126–134. PubMedCrossRef

19.

Kay, S. R., Fiszbein, A., & Opler, L. A. (1987). The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bulletin,13(2), 261–276. PubMedCrossRef

20.

Patrick, D. L., Burns, T., Morosini, P., Rothman, M., Gagnon, D. D., Wild, D., et al. (2009). Reliability, validity and ability to detect change of the clinician-rated Personal and Social Performance scale in patients with acute symptoms of schizophrenia. Current Medical Research and Opinion,25(2), 325–338. PubMedCrossRef

21.

Schumacker, R. E., & Lomax, R. G. (1996). A beginner’s guide to structural equation modeling. Mahwah, NJ: Lawrence Erlbaum Associates.

22.

Chassany, O., Sagnier, P., Marquis, P., Fullerton, S., & Aaronson, N. (2002). Patient-reported outcomes: The example of health-related quality of life: A European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Information Journal,36, 209–238. CrossRef

23.

Zumbo, B. D. (1999). A handbook on the Theory and Methods of Differential Item Functioning (DIF): Logistic Regression Modeling as a Unitary Framework for Binary and Likert-type (Ordinal) Item Scores. Ottawa, ON: Directorate of Human Resources Research and Evaluation, Department of National Defense.

24.

Gelin, M. N., & Zumbo, B. D. (2003). Differential Item Functioning results may change depending on how an item is scored: an illustration with the Center for Epidemiologic Studies Depression Scale. Educational and Psychological Measurement,63(1), 65–74. CrossRef

25.

Jodoin, M. G., & Gierl, M. J. (2001). Evaluating Type I error and power rates using an effect size measure with the logistic regression procedure for DIF detection. Applied Measurement in Education,14, 329–349. CrossRef

26.

Hays, R. D., Anderson, R. & Revicki, D. (1998). Assessing reliability and validity of measurement in clinical trials. In Quality of life assessment in clinical trials: Methods and practice (pp. 169–182). Oxford: Oxford University Press.

27.

Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory. New York: McGraw-Hill Inc.

28.

Guyatt, G. H., Deyo, R. A., Charlson, M., Levine, M. N., & Mitchell, A. (1989). Responsiveness and validity in health status measurements: A clarification. Journal of Clinical Epidemiology,42(5), 403–408. PubMedCrossRef

29.

Cohen, J. (1977). Statistical power analysis for the behavioral sciences. New York: Academic Press.

30.

Kline, R. B. (2005). Principle and practice of structural equation modeling. New York: Guilford Press.

31.

Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA,273(1), 59–65. PubMedCrossRef

32.

Arango, C., Nasrallah, H., Lawrie, S., Ochi Lohmann, T., Zhu, J., Garibaldi, G., et al. (2013) Efficacy and safety of adjunctive bitopertin (5 and 10 mg) versus placebo in subjects with persistent predominant negative symptoms of schizophrenia treated with antipsychotics—Results from the Phase III DayLyte study. In 4th Biennial Schizophrenia International Research Society Conference, 5–9 April 2013. Florence, Italy.

33.

Blaetter, T., Bugarski-Kirola, D., Fleischhacker, W. W., Bressan, R. A., Arango, C., Abi-Saab, D., et al. (2013). Efficacy and safety of adjunctive bitopertin (10 and 20 mg) versus placebo in subjects with persistent predominant negative symptoms of schizophrenia treated with antipsychotics—Results from the Phase III FlashLyte Study. In 4th Biennial Schizophrenia International Research Society Conference, 5–9 April 2013. Florence, Italy.

34.

Taha, N. A., Ibrahim, M. I., Rahman, A. F., Shafie, A. A., & Rahman, A. H. (2012). Validation of the Schizophrenia Quality of Life Scale Revision 4 among Chronic Schizophrenia Patients in Malaysia. Value in Health Regional Issues,1(1), 82–86. CrossRef

35.

Wilkinson, G., Clayson, D., Wild, D., Doll, H., Martin, C., & De Hert, M. (2004) The development and psychometric validation of the Schizophrenia Quality of Life Scale-revision 4 (SQLS-R4). Abstracts of the XIIth Biennal Winter Workshop on Schizophrenia. Schizophrenia Research. July 2, 2004.

36.

Galuppi, A., Turola, M. C., Nanni, M. G., Mazzoni, P., & Grassi, L. (2010). Schizophrenia and quality of life: How important are symptoms and functioning? International Journal of Mental Health Systems,4, 31. PubMedPubMedCentralCrossRef

37.

Lipkovich, I. A., Deberdt, W., Csernansky, J. G., Sabbe, B., Keefe, R. S., & Kollack-Walker, S. (2009). Relationships among neurocognition, symptoms and functioning in patients with schizophrenia: A path-analytic approach for associations at baseline and following 24 weeks of antipsychotic drug therapy. BMC Psychiatry,9, 44. PubMedPubMedCentralCrossRef

38.

Rabinowitz, J., Levine, S. Z., Garibaldi, G., Bugarski-Kirola, D., Berardo, C. G., & Kapur, S. (2012). Negative symptoms have greater impact on functioning than positive symptoms in schizophrenia: Analysis of CATIE data. Schizophrenia Research,137(1–3), 147–150. PubMedCrossRef

Titel: Health-related quality of life in patients with prominent negative symptoms: results from a multicenter randomized Phase II trial on bitopertin
Auteurs:: Diana Rofail
Antoine Regnault
Stéphanie le Scouiller
Carmen Galani Berardo
Daniel Umbricht
Ray Fitzpatrick
Publicatiedatum: 05-07-2015
DOI: https://doi.org/10.1007/s11136-015-1057-9
Uitgeverij: Springer International Publishing
Tijdschrift: Quality of Life Research An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation - Official Journal of the International Society of Quality of Life Research
Uitgave 1/2016
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649

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Abstract

Purpose

Methods

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