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Un estudio multicéntrico doble ciego controlado con placebo de sertralina en el tratamiento agudo y de continuación de la depresión mayor

Published online by Cambridge University Press:  12 May 2020

J. P. Olie ,
K. P. Gunn  and
E. Katz
J. P. Olie
Affiliation:
Hospital de Santa Ana, París, Francia
K. P. Gunn
Affiliation:
Pfizer Central Research, Ramsgate Road, Sandwich, Reino Unido
E. Katz
Affiliation:
Pfizer Central Research, París, Francia
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Resumen

En un estudio multicéntrico doble ciego de pacientes extemos con trastorno depresivo mayor según el DSM III-R, se valoraron 129 pacientes con sertralina y 129 con placebo durante un período de 6 semanas. La sertralina mostró un efecto antidepresivo, medido por la HAM-D, la MADRS, la CGI-S y la CGI-I, significativamente mayor (P < 0,001) en comparación con el placebo. En el subconjunto de pacientes con depresión grave (HAM-D en la línea de base > 25), la sertralina fue también significativamente más efectiva que el placebo (P < 0,05). Se comunicaron efectos secundario? con más frecuencia en los pacientes con sertralina (59%), en comparación con los pacientes con placebo (38%), siendo los más comunes la náusea, la jaqueca y el insomnio. Un subconjunto de 107 pacientes (66 con sertralina; 41 con placebo) que se definieron como pacientes con respuesta (CGI-I de 1 ó 2) después de 6 semanas de tratamiento participaron en una fase de continuación de 20 semanas. En este subconjunto con respuesta al tratamiento, hubo una mejoría continuada en ambos grupos de pacientes, pero sin diferencias significativas entre ellos en las puntuaciones medias de la HAM-D o la MADRS. Sin embargo, un número más alto de pacientes con sertralina (P < 0,05) se asoció con un patrón persistente de mejoría en relación con el placebo. La incidencia de efectos secundarios en los pacientes tratados con sertralina (52%) y con placebo (49%) en el período de continuación fue similar.

Keywords

SSRIsertralinadepresión mayor
Type
Artículo original
Information
European Psychiatry (Ed. Española) , Volume 4 , Issue 7 , October 1997 , pp. 434 - 444
Copyright
Copyright © European Psychiatric Association 1997

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