Hostname: page-component-586b7cd67f-rdxmf Total loading time: 0 Render date: 2024-11-22T08:04:36.293Z Has data issue: false hasContentIssue false
  • English
  • Français

Un ensayo comparativo doble ciego distribuido al azar de amisulprida frente a olanzapina durante 2 meses en el tratamiento de sujetos con esquizofrenia y depresion comorbida

Published online by Cambridge University Press:  12 May 2020

J. M. Vanelle  and
S. Douki
J. M. Vanelle
Affiliation:
Servicio de Psiquiatría, Hospital Saint-Jacques 85, rué Saint-Jacques, 44200Nantes, Francia
S. Douki
Affiliation:
Hópital Razi, La Manouba, Túnez
Get access

Resumen

Propόsito

Comparar la eficacia y la seguridad de la amisulprida y la olanzapina en sujetos con esquizofrenia y depresiόn comόrbida en un ensayo doble ciego distribuido al azar.

Pacientes

Se distribuyό al azar a amisulprida (200-600 mg/día) u olanzapina (5-15 mg/dia) durante 8 semanas a 85 pacientes adultos que cumplían los criterios del DSM-IV para esquizofrenia y presentaban un episodio depresivo. Las variables de eficacia primaria fueron el cambio en la puntuaciόn de la Escala de Depresiόn de Calgary (CDS) y la Impresiόn Clínica Global (CGI) de cambio. La seguridad se vigilό por los informes de acontecimientos adversos y la determinaciόn de la funciόn extrapiramidal y las variables metabόlicas.

Resultados

El cambio medio desde la línea de base de la puntuaciόn de la CDS fue -6,84 en el grupo de amisulprida y -7,36 en el grupo de olanzapina. Se consideraron “mucho” o “muchisimo” mejor, respectivamente, 65,9% y 61,5% de los sujetos. No se observaron diferencias intergrupo significativas en el tamaño del efecto. La frecuencia de acontecimientos adversos fue baja y no se vio apariciόn de síntomas extrapiramidales. Cuatro pacientes en el grupo de olanzapina desarrollaron concentraciones anormales de triglicéridos. El aumento medio de peso fue 1,45 y 0,5 kg, respectivamente, en los grupos de olanzapina y amisulprida.

Conclusion

La amisulprida y la olanzapina son efectivas en los pacientes con esquizofrenia y depresiόn comόrbida. La tolerancia de ambos fármacos fue aceptable, aunque el uso de olanzapina se asociaba con una tendencia a efectos secundarios metabόlicos mayores [19].

Keywords

AmisulpridaOlanzapinaEsquizofreniaDepresiόnEnsayo clínico distribuido al azar
Type
Artículo original
Information
European Psychiatry (Ed. Española) , Volume 14 , Issue 4 , May 2007 , pp. 181 - 189
Copyright
Copyright © European Psychiatric Association 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Addington, D, Addington, J, Maticka-Tyndale, E. Assessing depression in schizophrenia. The Calgary Depression Scale. Br J Psychiatry 1992; 163(Suppl 22):39–44.CrossRefGoogle Scholar
Addington, D, Addington, J, Maticka-Tyndale, E, Joyce, J. Reliability and validity of a depression rating scale for schizophrenics. Schizophr Res 1993;6:201–8.CrossRefGoogle Scholar
Allison, DB, Casey, DE. Antipsychotic-induced weight gain: a review of the literature. J Clin Psychiatry 2001;62(Suppl 7):22–31.Google ScholarPubMed
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC, USA: American Psychiatric Association; 1994.Google Scholar
Barnes, TRE. A rating scale for akathisia. Br J Psychiatry 1984;154:672–3.CrossRefGoogle Scholar
Bell, M, Milstein, R, Beam-Gould, J, Cicchetti, D. The Positive and Negative Syndrome Scale and the Brief Psychiatric Rating Scale. Reliability, comparability and predictive validity. J Nerv Ment Dis 1992;180:723–8.CrossRefGoogle ScholarPubMed
Boyer, P, Lecrubier, Y, Stalla-Bourdillon, A, Fleurot, O. Amisulpride versus amineptine and placebo for the treatment o f dysthymia. Neuropsychobiology 1999;39:25–32.CrossRefGoogle Scholar
Collaborative Working Group on clinical trial evaluations. Atypical antipsychotics for treatment o f depression in schizophrenia and affective disorders. J Clin Psychiatry 1998;59(Suppl 12):41–5.Google Scholar
Coulouvrat, C, Dondey-Nouvel, L. Safety of amisulpride (Solian): a review o f 11 clinical studies. Int Clin Psychopharmacol 1999;14:209–18.CrossRefGoogle Scholar
Duggan, L, Fenton, M, Rathbone, J, Dardennes, RM, El-Dosoky, A, Indran, S. Olanzapine for schizophrenia. Cochrane Database Syst Rev 2003(1) [CD001359].Google Scholar
Kay, SR, Fiszbzin, A, Opler, LA. The Positive and Negative Syndrome Scale for schizophrenia. Schizophr Bull 1987;3:261–76.CrossRefGoogle Scholar
Koro, CE, Fedder, DO, L'ltalien, GJ, Weiss, SS, Magder, LS, Kreyenbuhl, J, et al. An assessment of the independent effects of olanzapine and risperidone exposure on the risk o f hyperlipidemia in schizophrenic subjects. Arch Gen Psychiatry 2002;59:1021–6.CrossRefGoogle Scholar
Koro, CE, Fedder, DO, L’ltalien, GJ, Weiss, SS, Magder, LS, Kreyenbuhl, J, et al. Assessment of independent effect of olanzapine and risperidone on risk of diabetes among subjects with schizophrenia: population based nested case-control study. BMJ 2002;325:243–8.CrossRefGoogle Scholar
Lecrubier, Y, Boyer, P, Turjanski, S, Rein, W. Amisulpride versus imiprimine and placebo in dysthymia and major depression. Amisulpride Study Group. J Affect Disord 1997;43:95–103.CrossRefGoogle Scholar
Leucht, S, Pitschel-Walz, G, Engel, RR, Kissling, W. Amisulpride, an unusual “atypical” antipsychotic: a meta-analysis of randomized controlled triais. Am J Psychiatry 2002;159:180–90.CrossRefGoogle Scholar
Martin, S, Löo, H, Peuskens, J, Thirumalai, S, Giudicelli, A, Fleurot, O. A double-blind randomised comparative trial of amisulpride versus olanzapine in the treatment o f schizophrenia: short-term results at two months. Curr Med Res Opin 2002;18:355–62.CrossRefGoogle Scholar
Meltzer, HY. Treatment of suicidality in schizophrenia. Ann N Y Acad Sci 2001;932:44–60.CrossRefGoogle Scholar
Meltzer, HY, Alphs, L, Green, AI, Altamura, AC, Anand, R, Bertoldi, A, et al. Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial (InterSePT). Arch Gen Psychiatry 2003;60:82–91.CrossRefGoogle Scholar
Möller, HJ, Boyer, P, Fleurot, O, Rein, W. Improvement of acute exacerbations of schizophrenia with amisulpride: a comparison with haloperidol. PROD-ASLP Study Group. Psychopharmacology (Berl) 1997;132:396–401.Google ScholarPubMed
Mortimer, A, Martin, S, Loo, H. Peuskens J for the SOLIANOL Study Group A double-blind randomised comparative trial of amisulpride versus olanzapine for six months in the treatment of schizophrenia. Int Clin Psychopharmacol 2004;19:63–9.CrossRefGoogle Scholar
National Institute of Mental Health. CGI, Abnormal involuntary Movement Scale. In: Guy, W, editor. ECDEU assessment manual of psychopharmacology review. Rockville, USA: NIMH; 1976. p.534–7.Google Scholar
National Institute of Mental Health. CGI, Clinical Global Impression. In: Guy, W, editor. ECDEU assessment manual of psychopharmacology review. Rockville, USA: NIMH; 1976. p. 217-22.Google Scholar
Overall, JE, Gorham, DR. The Brief Psychiatric Rating Scale. Psychol Rep 1962;10:799–812.CrossRefGoogle Scholar
Papp, M, Wieronska, J. Antidepressant-like activity of amisulpride in two animal models of depression. J Psychopharmacol 2000; 14:46- 52.CrossRefGoogle ScholarPubMed
Peuskens, J, Moller, HJ, Peuch, A. Amisulpride improves depressive symptoms in acute exacerbations of schizophrenia: comparison with haloperidol and risperidone. Eur Neuropsychopharmacol 2002; 12:305–10.CrossRefGoogle ScholarPubMed
Peuskens, J, van Baelen, B, de Smedt, C, Lemmens, P. Effects of risperidone on affective symptoms with schizophrenia. Int Clin Psychopharmacol 2000;15:343–9.CrossRefGoogle ScholarPubMed
Ravizza, L. Amisulpride in medium-term treatment of dysthymia: a six-month, double-blind safety study versus amitriptyline. AMILONG investigators. J Psychopharmacol 1999;13:248–54.CrossRefGoogle ScholarPubMed
Schoemaker, H, Claustre, Y, Fage, D, Rouquier, L, Chergui, K, Curet, O, et al. Neurochemical characteristics of amisulpride, an atypical dopamine D2/D3 receptor antagonist with both presynaptic and limbic selectivity. J Pharmacol Exp Ther 1997;280:83–97.Google ScholarPubMed
Simpson, G, Angus, JA. A rating scale for extrapyramidal symptoms. Acta Psychiatr Scand 1970;45(Suppl 42): 11–9.CrossRefGoogle Scholar
Siris, SG. Depression in schizophrenia: perspective in the era of “atypical” antipsychotic agents. Am J Psychiatry 2000;157:1379–89.CrossRefGoogle ScholarPubMed
Tollefson, GD, Anderson, SW. Should we consider mood disturbance in schizophrenia as an important determinant of quality of life? J Clin Psychiatr 1999;60(Suppl 5):23–9.Google ScholarPubMed
Tollefson, GD, Sanger, TM, Beasley, CM, Tran, PV. A double-blind comparison of the novel antipsychotic olanzapine versus haloperidol or placebo on anxious and depressive symptoms accompanying schizophrenia. Biol Psychiatry 1998;43:803–10.CrossRefGoogle ScholarPubMed
Tran, PV, Dellva, MA, Tollefson, GD, Beasley, CM Jr, Potvin, JH, Kiesler, GM. Extrapyramidal symptoms and tolerability of olanzapine versus haloperidol in acute treatment of schizophrenia. J Clin Psych 1997;52 (Suppl 10):205–11.CrossRefGoogle Scholar