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Mifepristone

A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression

Ensayo de CORCEPT THERAPEUTICS INC en Trastorno depresivo mayor.

Fase

Fase 3

Estado

Completado

Participantes

87

previstos

Centros

13

Fin del objetivo primario

nov 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2005.

Qué mide

Evaluar la seguridad y la tolerabilidad de Corlux (mifepristona) para el tratamiento de sintomas psicoticos recurrentes con depresion mayor con caracteristicas psicoticas (PMD) que hubieran participado previamente en el Protocolo C-1073-07 de Corcept Therapeutics

Cómo lo describe el promotor

En el documentoEn inglés, del registroCorlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.

Más ensayos de CORT

Todos los de CORT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00208156), actualizada en feb 2012.