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La valpromida aumenta la amplitud del ritmo circadiano de la frecuencia cardíaca en los trastornos bipolares y unipolares en remisión. Un estudio controlado con placebo

Published online by Cambridge University Press:  12 May 2020

P. Lemoine
Affiliation:
Unidad Clinica de Psiquiatría Biológica, CH Le Vinatier, 95, Boulevard Pinel, 69677Lyon-Bron, Francia Centro de Investigatión Philippe Pinel, Avenue Bourassa, Montreal, Quebec, Canadá
J. Fondarai
Affiliation:
Servicio de medicina del deporte, Hospital del Salvador, Marsella, Francia
T. Faivre
Affiliation:
Unidad Clinica de Psiquiatría Biológica, CH Le Vinatier, 95, Boulevard Pinel, 69677Lyon-Bron, Francia
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Resumen

El propósito de este estudio era investigar los efectos de la valpromida sobre el ritmo circadiano de la frecuencia cardíaca en los trastornos unipolares y bipolares recurrentes en remisión (DSM-III-R). Consistió en un estudio de grupos cruzados repetido comparativo, distribuido al azar, doble ciego de valpromida frente a placebo durante períodos de cuatro semanas. El criterio fundamental de evaluación era la frecuencia cardíaca (FC). Los criterios secundarios comprendían la actividad motora (AM) y la Escala de Evaluación de la Manía de Bech y Rafaelsen, el Cuestionario de Home y Ostberg, la Escala de Evaluación de la Depresión de Montgomery y Åsberg, el Cuestionario de Spiegel, un diario del sueño y la Impresión Clínica Global. Se incluyó a 15 pacientes, lo que dio 60 períodos de un mes (30 períodos con valpromida y 30 con placebo). El análisis cosinor de la FC y la AM reveló una diferencia en la amplitud (P = 0,037, análisis de varianza, prueba unilateral). El estudio clínico del sueño muestra que la duración del sueño era mayor con la valpromida que con el placebo (P = 0,007, prueba unilateral). Del mismo modo, la evaluación de la calidad del sueño por los pacientes mismos mostró que la valpromida era superior al placebo (P = 0,045, prueba unilateral). Los resultados del análisis del cuestionario de Spiegel confirman también la superioridad de la valpromida sobre el placebo. La seguridad y el cumplimiento terapéutico fueron comparables para el fármaco activo y el placebo. En conclusión, el tamaño relativamente pequeño de la muestra requiere una interpretación cautelosa de este estudio. Sin embargo, estos resultados iniciales muestran un efecto claro de la valpromida sobre un ritmo biológico, lo que lleva a uno a suponer que este fármaco puede ser efectivo por medio de un efecto de “sincronización”.

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Artículo original

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References

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