Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study

Journal of Psychiatric Research

Volumn 47, Issue 5, 2013, Pages 670-677

  Nasrallah, Henry A ^a   Silva, Robert ^b   Phillips, Debra ^b   Cucchiaro, Josephine ^b   Hsu, Jay ^b   Xu, Jane ^b   Loebel, Antony ^b  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b DAINIPPON SUMITOMO PHARMA CO LTD   (Japan)

Author keywords

Antipsychotic agents; Atypical; Clinical study; Efficacy; Lurasidone; Schizophrenia

Indexed keywords

AMANTADINE; BENZATROPINE; BIPERIDEN; DIPHENHYDRAMINE; LORAZEPAM; LURASIDONE; PLACEBO; PROPRANOLOL; TEMAZEPAM; TRIHEXYPHENIDYL;

ADULT; AGED; AGITATION; AKATHISIA; ARTICLE; BACKACHE; CHOLECYSTITIS; COMPLEX PARTIAL SEIZURE; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSTONIA; ELECTROCARDIOGRAM; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HEADACHE; HUMAN; INSOMNIA; LABORATORY TEST; LACTATE DEHYDROGENASE BLOOD LEVEL; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MENTAL PATIENT; MUSCULOSKELETAL STIFFNESS; NAUSEA AND VOMITING; OUTCOME ASSESSMENT; PARKINSONISM; POSITIVE AND NEGATIVE SYNDROME SCALE; PRIORITY JOURNAL; PROLACTIN BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SOMNOLENCE; STAPHYLOCOCCUS INFECTION; STATISTICAL SIGNIFICANCE; VITAL SIGN; WEIGHT GAIN;

EID: 84875270413     PISSN: 00223956     EISSN: 18791379     Source Type: Journal    
DOI: 10.1016/j.jpsychires.2013.01.020     Document Type: Article

References (30)

1. American Diabetes Association American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Journal of Clinical Psychiatry 2004, 65:267-272.
2. Diagnostic and statistical manual of mental disorders 1994, American Psychiatric Association, American Psychiatric Press, Washington, DC, (DSM-IV). 4th ed.
3. Arranz M.J., de Leon J. Pharmacogenetics and pharmacogenomics of schizophrenia: a review of last decade of research. Molecular Psychiatry 2007, 12:707-747.
4. Barnes T.R.E. A rating scale for drug-induced akathisia. British Journal of Psychiatry 1989, 154:672-676.
5. Brechenmacher T., Xu J., Dmitrienko A., Tamhane A.C. A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. Journal of Biopharmaceutical Statistics 2011, 21:748-767.
6. Citrome L. Lurasidone for the acute treatment of adults with schizophrenia: what is the number needed to treat, number needed to harm, and likelihood to be helped or harmed?. Clinical Schizophrenia & Related Psychoses 2012, 6:76-85.
7. Correll C.U., Leucht S., Kane J.M. Lower risk for tardive dyskinesia associated with second-generation antipsychotics: a systematic review of 1-year studies. American Journal of Psychiatry 2004, 161:414-425.
8. Guy W.A. Abnormal Involuntary Movement Scale (AIMS). ECDEU assessment manual for psychopharmacology, revised 1976, 534-537. National Institute of Mental Health, Rockville, MD, US Department of Health, Education, and Welfare Pub. No. (ADM) 76-338.
9. Henderson D.C., Cagliero E., Copeland P.M., Borba C.P., Evins E., Hayden D., et al. Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Archives of General Psychiatry 2005, 62:19-28.
10. Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 1988, 75:383-386.
11. 1A receptor activity. Journal of Pharmacology and Experimental Therapeutics 2010, 334:171-181.
12. Kay S.R., Fiszbein A., Opler L. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophrenia Bulletin 1987, 13:261-276.
13. Kemp A.S., Schooler N.H., Kalali A.H., Alphs L., Anand R., Awad G., et al. What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it?. Schizophrenia Bulletin 2010, 36:504-509.
14. Khin N.A., Chen Y.-F., Yang Y., Yang P., Laughren T.P. Exploratory analyses of efficacy data from schizophrenia trials in support of New Drug Applications submitted to the US Food and Drug Administration. Journal of Clinical Psychiatry 2012, 73:856-864.
15. Koro C.E., Fedder D.O., L'Italien G.J., Weiss S., Magder L.S., Kreyenbuhl J., et al. An assessment of the independent effects of olanzapine and risperidone exposure on the risk of hyperlipidemia in schizophrenic patients. Archives of General Psychiatry 2002, 59:1021-1026.
16. Latuda (lurasidone HCl) Tablets US prescribing information May 2012, Accessed 11.12.12. http://www.latuda.com/LatudaPrescribingInformation.pdf.
17. Leucht S., Corves C., Arbter D., Engel R.R., Li C., Davis J.M. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 2009, 373:31-41.
18. Liang K., Zeger S. Longitudinal data analysis for continuous and discrete responses for pre-post designs. Sankhya: The Indian Journal of Statistics 2000, 62:134-148.
19. Lieberman J.A., Stroup T.S., McEvoy J.P., Swartz M.S., Rosenheck R.A., Perkins D.O., et al. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine 2005, 353:1209-1223.
20. Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu J, Kalali AH, et al. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophrenia Research, in press.
21. Meltzer H.Y., Cucchiaro J., Silva R., Ogasa M., Phillips D., Xu J., et al. Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study. American Journal of Psychiatry 2011, 168:957-967.
22. Montgomery S.A., Åsberg M. A new depression scale designed to be sensitive to change. British Journal of Psychiatry 1979, 134:382-389.
23. Nakamura M., Ogasa M., Guarino J., Phillips D., Severs J., Cucchiaro J., et al. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. Journal of Clinical Psychiatry 2009, 70:829-836.
24. Newcomer J.W. Antipsychotic medications: metabolic and cardiovascular risk. Journal of Clinical Psychiatry 2007, 68(Suppl. 4):8-13.
25. Ogasa M., Kimura T., Nakamura M., Guarino J. Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. Psychopharmacology 2013, 225:519-530.
26. Regier D.A., Narrow W.E., Rae D.S., Manderscheid R.W., Locke B.Z., Goodwin F.K. The de facto US mental and addictive disorders service system: epidemiologic catchment area prospective 1-year prevalence rates of disorders and services. Archives of General Psychiatry 1993, 50:85-94.
27. Saha S., Chant D., Welham J., McGrath J. A systematic review of the prevalence of schizophrenia. PLoS Medicine 2005, 2:e141.
28. Sheehan D.V., Lecrubier Y., Sheehan K.H., Amorim P., Janavs J., Weiller E., et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry 1998, 59(Suppl. 20):22-33.
29. Simpson G.M., Angus J.W. A rating scale for extrapyramidal side effects. Acta Psychiatrica Scandinavica 1970, 212(Suppl.):11-19.
30. Tenback D.E., vanHarten P.N., Slooff C.J., Belger M.A., van Os J., SOHO Study Group Effects of antipsychotic treatment on tardive dyskinesia: a 6-month evaluation of patients from the European Schizophrenia Outpatient Health Outcomes (SOHO) Study. Journal of Clinical Psychiatry 2005, 66:1130-1133.