A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project

International Journal of Neuropsychopharmacology

Volumn 19, Issue 4, 2016, Pages

  Bioque, Miquel ^a   Llerena, Adrián ^b   Cabrera, Bibiana ^a   Mezquida, Gisela ^a   Lobo, Antonio ^c   González Pinto, Ana ^d   Díaz Caneja, Covadonga M ^e   Corripio, Iluminada ^f   Aguilar, Eduardo J ^g   Bulbena, Antoni ^h   Castro Fornieles, Josefina ⁱ   Vieta, Eduard ⁱ   Lafuente, Amàlia ⁱ   Mas, Sergi ⁱ   Parellada, Mara ^e   Saiz Ruiz, Jerónimo ^j   Cuesta, Manuel J ^k   Bernardo, Miguel ^a,i   Gassó, Patricia ^l   Amoretti, Silvia ^l   García Bernardo, Enrique ^l   Tapia Casellas, Cecilia ^l   Alonso Solís, Anna ^l   Grasa, Eva ^l   Hernández, Miryam ^l   González, Itxaso ^l   Ruiz, Pedro ^l   Modrego, Fabiola ^l   Escartí, Maria Jose ^l   Mané, Anna ^l   Torrent, Carla ^l   Baeza, Inmaculada ^l   Contreras, Fernando ^l   Albacete, Auria ^l   Bobes, Julio ^l   García Portilla, Ma Paz ^l   Zabala Rabadán, Arantzazu ^l   Segarra Echevarría, Rafael ^l   Rodriguez Jimenez, Roberto ^l   Morales Muñoz, Isabel ^l   Butjosa, Anna ^l   Landin Romero, Ramon ^l   Sarró, Salvador ^l   Ibáñez, Ángela ^l   Sánchez Torres, Ana Ma ^l   Balanzá Martínez, Vicent ^l   more..

^a HOSPITAL CLÍNIC   (Spain)

^b UNIVERSITY OF EXTREMADURA   (Spain)

^c UNIVERSITY OF ZARAGOZA   (Spain)

^d UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^e UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^f HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^g UNIVERSITY OF VALENCIA   (Spain)

^h HOSPITAL DEL MAR   (Spain)

ⁱ UNIVERSITY OF BARCELONA   (Spain)

^j HOSPITAL RAMÓN Y CAJAL   (Spain)

^k Recinto de Complejo Hospitalario de Navarra   (Spain)

^l NONE

more..

Author keywords

Antipsychotic; first episode psychosis; pharmacovigilance; polytherapy; psychotropic drugs; schizophrenia

Indexed keywords

ANTIDEPRESSANT AGENT; BENZODIAZEPINE DERIVATIVE; CHOLINERGIC RECEPTOR BLOCKING AGENT; CLOZAPINE; MOOD STABILIZER; NEUROLEPTIC AGENT;

ADOLESCENT; ADULT; ARTICLE; CHILD; CLINICAL PRACTICE; COGNITIVE DEFECT; DRUG SURVEILLANCE PROGRAM; ENDOCRINE DISEASE; EXTRAPYRAMIDAL SYMPTOM; FEMALE; FOLLOW UP; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL RESEARCH; MONOTHERAPY; PRESCRIPTION; PRIORITY JOURNAL; PSYCHOPHARMACOLOGY; PSYCHOPHARMACOTHERAPY; PSYCHOSIS; SEDATION; SEXUAL DYSFUNCTION; SIDE EFFECT; WEIGHT GAIN; ACUTE DISEASE; CLINICAL TRIAL; MULTICENTER STUDY; POLYPHARMACY; PSYCHOLOGICAL RATING SCALE; PSYCHOTIC DISORDERS; SEX DIFFERENCE; SPAIN; STATISTICAL MODEL; TREATMENT OUTCOME; YOUNG ADULT;

ACUTE DISEASE; ADOLESCENT; ADULT; ANTIPSYCHOTIC AGENTS; CHILD; FEMALE; HUMANS; LOGISTIC MODELS; MALE; PHARMACOVIGILANCE; POLYPHARMACY; PSYCHIATRIC STATUS RATING SCALES; PSYCHOTIC DISORDERS; SEX FACTORS; SPAIN; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84966349657     PISSN: 14611457     EISSN: 14695111     Source Type: Journal    
DOI: 10.1093/ijnp/pyv121     Document Type: Article

References (56)

1. AEMPS (2014) Agencia Española de Medicamentos y Productos Sanitarios. In: Agencia Española De Medicamentos Y Productos Sanitarios.
2. Alvarez-Jimenez M, Parker AG, Hetrick SE, McGorry PD, Gleeson JF (2009) Preventing the second episode: a systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophr Bull 37:619-630.
3. American Psychiatric Association (1994) DSM-IV: diagnostic and statistical manual of mental disorders, 4th Edition. Washington, DC: American Psychiatric Association.
4. American Psychiatric Association (2004) Practice guidelines for the treatment of patients with schizophrenia. Washington, DC.
5. Arango C, Rapado-Castro M, Reig S, Castro-Fornieles J, Gonzalez-Pinto A, Otero S, Baeza I, Moreno C, Graell M, Janssen J, Parellada M, Moreno D, Bargallo N, Desco M (2012) Progressive brain changes in children and adolescents with first-episode psychosis. Arch Gen Psychiatry 69:16-26.
6. Barnes TR, Psychopharmacology tSCGotBAf (2011) Evidence-based guidelines for the pharmacological treatment of schizophrenia: recommendations from the British Association for Psychopharmacology. J Psychopharmacol 25:567-620.
7. Bernardo M, Bioque M (2014) What have we learned from research into first-episode psychosis? Rev Psiquiatr Salud Ment 7:61-63.
8. Bernardo M, Coma A, Ibanez C, Zara C, Bari JM, Serrano-Blanco A (2012) Antipsychotic polypharmacy in a regional health service: a population-based study. BMC Psychiatry 12:42.
9. Bernardo M, Bioque M, Parellada M, Saiz Ruiz J, Cuesta MJ, Llerena A, Sanjuan J, Castro-Fornieles J, Arango C, Cabrera B (2013) Assessing clinical and functional outcomes in a gene-environment interaction study in first episode of psychosis (PEPs). Rev Psiquiatr Salud Ment 6:4-16.
10. Bertani M, Lasalvia A, Bonetto C, Tosato S, Cristofalo D, Bissoli S, De Santi K, Mazzoncini R, Lazzarotto L, Santi M, Sale A, Scalabrin D, Abate M, Tansella M, Ruggeri M (2011) The influence of gender on clinical and social characteristics of patients at psychosis onset: a report from the Psychosis Incident Cohort Outcome Study (PICOS). Psychol Med:1-12.
11. Bertelsen M, Jeppesen P, Petersen L, Thorup A, Ohlenschlaeger J, le Quach P, Christensen TO, Krarup G, Jorgensen P, Nordentoft M (2008) Five-year follow-up of a randomized multicenter trial of intensive early intervention vs standard treatment for patients with a first episode of psychotic illness: the OPUS trial. Arch Gen Psychiatry 65:762-771.
12. Bioque M, Garcia-Bueno B, Macdowell KS, Meseguer A, Saiz PA, Parellada M, Gonzalez-Pinto A, Rodriguez-Jimenez R, Lobo A, Leza JC, Bernardo M (2013) Peripheral endocannabinoid system dysregulation in first-episode psychosis. Neuropsychopharmacology: official publication of the American College of Neuropsychopharmacology 38:2568-2577.
13. Buchanan RW, Kreyenbuhl J, Kelly DL, Noel JM, Boggs DL, Fischer BA, Himelhoch S, Fang B, Peterson E, Aquino PR, Keller W, Schizophrenia Patient Outcomes Research T (2010) The 2009 schizophrenia PORT psychopharmacological treatment recommendations and summary statements. Schizophr Bull 36:71-93.
14. Castro-Fornieles J, Parellada M, Soutullo CA, Baeza I, Gonzalez-Pinto A, Graell M, Paya B, Moreno D, de la Serna E, Arango C (2008) Antipsychotic treatment in child and adolescent first-episode psychosis: a longitudinal naturalistic approach. J Child Adolesc Psychopharmacol 18:327-336.
15. Correll CU (2014) Recognition of patients who would benefit from LAI antipsychotic treatment: how to assess adherence. J Clin Psychiatry 75:e29.
16. Crossley NA, Constante M, McGuire P, Power P (2010) Efficacy of atypical v. typical antipsychotics in the treatment of early psychosis: meta-analysis. Br J Psychiatry 196:434-439.
17. Deutsche Gesellschaft für Psychiatrie Psychotherapie und Nervenheilkunde (2006) Praxisleitlinien in Psychiatrie und Psychotherapie. In: Steinkopff Verlag, Darmstadt.
18. Dold M, Li C, Tardy M, Khorsand V, Gillies D, Leucht S (2012) Benzodiazepines for schizophrenia. The Cochrane database of systematic reviews 11:CD006391.
19. Endicott J, Spitzer RL, Fleiss JL, Cohen J (1976) The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry 33:766-771.
20. First M, Spitzer R, Gibbon M, Williams J, eds (1994) Structured Clinical Interview for DSM-IV Axis I Disorders. Administration booklet. Washington, DC: American Psychiatric Press Inc.
21. First M, Spitzer R, Gibbon M, Williams J, eds (1999) SCID-II: guía del usuario para la entrevista clínica estructurada para los trastornos de la personalidad. Barcelona: Masson.
22. Gallego JA, Bonetti J, Zhang J, Kane JM, Correll CU (2012) Prevalence and correlates of antipsychotic polypharmacy: a systematic review and meta-regression of global and regional trends from the 1970s to 2009. Schizophr Res 138:18-28.
23. Gardner DM, Murphy AL, O'Donnell H, Centorrino F, Baldessarini RJ (2010) International consensus study of antipsychotic dosing. Am J Psychiatry 167:686-693.
24. Girgis RR, Phillips MR, Li X, Li K, Jiang H, Wu C, Duan N, Niu Y, Lieberman JA (2011) Clozapine v. chlorpromazine in treatment-naive, first-episode schizophrenia: 9-year outcomes of a randomised clinical trial. Br J Psychiatry 199:281-288.
25. Grupo de trabajo de la Guía de Práctica Clínica sobre la Esquizofrenia y el Trastorno Psicótico Incipiente. Fòrum de Salut Mental cPdCpeSNd (2009) Guía de Práctica Clínica sobre la Esquizofrenia y el Trastorno Psicótico Incipiente. Madrid (Spain).
26. IBM Corp (2011) IBM SPSS Statistics for Windows. In 20.0 Edition. Armonk, NY: IBM Corp
27. Kahn RS, Fleischhacker WW, Boter H, Davidson M, Vergouwe Y, Keet IP, Gheorghe MD, Rybakowski JK, Galderisi S, Libiger J, Hummer M, Dollfus S, Lopez-Ibor JJ, Hranov LG, Gaebel W, Peuskens J, Lindefors N, Riecher-Rossler A, Grobbee DE (2008) Effectiveness of antipsychotic drugs in first-episode schizophrenia and schizophreniform disorder: an open randomised clinical trial. Lancet 371:1085-1097.
28. Kapur S, Phillips AG, Insel TR (2012) Why has it taken so long for biological psychiatry to develop clinical tests and what to do about it? Mol Psychiatry 17:1174-1179.
29. Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N (1997) Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 36:980-988.
30. Kay SR, Fiszbein A, Opler LA (1987) The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull 13:261-276.
31. Kishimoto T, Robenzadeh A, Leucht C, Leucht S, Watanabe K, Mimura M, Borenstein M, Kane JM, Correll CU (2014) Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophrenia bulletin 40:192-213.
32. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, Samara M, Barbui C, Engel RR, Geddes JR, Kissling W, Stapf MP, Lassig B, Salanti G, Davis JM (2013) Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet 382:951-962.
33. Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K (1987) The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl 334:1-100.
34. Malla A, Tibbo P, Chue P, Levy E, Manchanda R, Teehan M, Williams R, Iyer S, Roy MA (2013) Long-acting injectable antipsychotics: recommendations for clinicians. Can J Psychiatr 58:30S-35S.
35. Manchanda R, Chue P, Malla A, Tibbo P, Roy MA, Williams R, Iyer S, Lutgens D, Banks N (2013) Long-acting injectable antipsychotics: evidence of effectiveness and use. Can J Psychiatr 58:5S-13S.
36. Mas S, Llerena A, Saiz J, Bernardo M, Lafuente A (2012) Strengths and weaknesses of pharmacogenetic studies of antipsychotic drugs: the potential value of the PEPs study. Pharmacogenomics 13:1773-1782.
37. McEvoy JP, Lieberman JA, Perkins DO, Hamer RM, Gu H, Lazarus A, Sweitzer D, Olexy C, Weiden P, Strakowski SD (2007) Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison. Am J Psychiatry 164:1050-1060.
38. Montgomery SA, Asberg M (1979) A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389.
39. National Institute of Clinical Excellence (2009) Clinical Guideline 82. Schizophrenia: core interventions in the treatment and management of schizophrenia in primary and secondary care. London: NICE.
40. Patel M, Haddad P, Chaudhry I, McLoughlin S, David A (2010) Psychiatrists' use, knowledge and attitudes to first- and second-generation antipsychotic long-acting injections: comparisons over 5 years. J Psychopharmacol 24:1473-1482.
41. Perala J, Suvisaari J, Saarni SI, Kuoppasalmi K, Isometsa E, Pirkola S, Partonen T, Tuulio-Henriksson A, Hintikka J, Kieseppa T, Harkanen T, Koskinen S, Lonnqvist J (2007) Lifetime prevalence of psychotic and bipolar I disorders in a general population. Arch Gen Psychiatry 64:19-28.
42. Robinson DG, Schooler NR, John M, Correll CU, Marcy P, Addington J, Brunette MF, Estroff SE, Mueser KT, Penn D, Robinson J, Rosenheck RA, Severe J, Goldstein A, Azrin S, Heinssen R, Kane JM (2015) Prescription practices in the treatment of first-episode schizophrenia spectrum disorders: data from the national RAISE-ETP study. Am J Psychiatry 172:237-248.
43. Rybakowski JK, Vansteelandt K, Remlinger-Molenda A, Fleischhacker WW, Kahn RS, Peuskens J (2014) Extrapyramidal symptoms during treatment of first schizophrenia episode: Results from EUFEST. European Neuropsychopharmacology.
44. Sanz-Fuentenebro J, Taboada D, Palomo T, Aragües M, Ovejero S, Del Alamo C, Molina V (2013) Randomized trial of clozapine vs. risperidone in treatment-nai¨ve first-episode schizophrenia: Results after one year. Schizophr Res 149:156-161.
45. Sendt KV, Tracy DK, Bhattacharyya S (2015) A systematic review of factors influencing adherence to antipsychotic medication in schizophrenia-spectrum disorders. Psychiatry Res 225:14-30.
46. Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S (1983) A children's global assessment scale (CGAS). Arch Gen Psychiatry 40:1228-1231.
47. Simpson GM, Angus JW (1970) A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 212:11-19.
48. Stahl SM (2014) Long-acting injectable antipsychotics: shall the last be first? CNS Spectrums 19:3-5.
49. Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH (2015) Longacting injectable risperidone for relapse prevention and control of breakthrough symptoms after a recent first episode of schizophrenia: a randomized clinical trial. JAMA Psychiatry 72:822-829.
50. Tani H, Uchida H, Suzuki T, Fujii Y, Mimura M (2013) Interventions to reduce antipsychotic polypharmacy: A systematic review. Schizophrenia Research 143:215-220.
51. Tiihonen J, Haukka J, Taylor M, Haddad PM, Patel MX, Korhonen P (2011) A nationwide cohort study of oral and depot antipsychotics after first hospitalization for schizophrenia. The American journal of psychiatry 168:603-609.
52. Torniainen M, Mittendorfer-Rutz E, Tanskanen A, Bjorkenstam C, Suvisaari J, Alexanderson K, Tiihonen J (2014) Antipsychotic Treatment and Mortality in Schizophrenia. Schizophr Bull.
53. WHO (2014) World Health Organization ATC DDD index. In, http://www.whocc.no/atc-ddd-index/ Edition: World Health Organization.
54. Young RC, Biggs JT, Ziegler VE, Meyer DA (1978) A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 133:429-435.
55. Zhang J-P, Gallego JA, Robinson DG, Malhotra AK, Kane JM, Correll CU (2013) Efficacy and safety of individual second-generation vs. first-generation antipsychotics in first-episode psychosis: a systematic review and meta-analysis. Int J Neuropsychopharmacol 16:1205-1218.
56. Zhornitsky S, Stip E (2012) Oral versus long-acting injectable antipsychotics in the treatment of schizophrenia and special populations at risk for treatment nonadherence: a systematic review. schizophrenia research and treatment. 2012:12.