Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications / Ni A. Khin en The Journal of Clinical Psychiatry, Año 2011 - Vol.72 - No. 4 (Abril)

Público ISBD [artículo]  inThe Journal of Clinical Psychiatry > Año 2011 - Vol.72 - No. 4 (Abril) . - pp. 464-472 Título : Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications Tipo de documento: texto impreso Autores: Ni A. Khin, Autor ; Yeh Fong Chen, Autor ; Yang Yang, Autor Fecha de publicación: 2022 Artículo en la página: pp. 464-472 Idioma : Inglés (eng) Idioma original : Inglés (eng) Palabras clave: Antidepresivos, Trastorno depresivo mayor, Aprobación de medicamentos, Efecto placebo, Ensayos controlados aleatorios. Resumen: There has been concern about a high rate of placebo response and a substantial failure rate in recent clinical trials in major depressive disorder (MDD). This report explores differences in efficacy data from placebo-controlled MDD trials submitted in support of new drug applications (NDAs) over a 25-year period. Link: ./index.php?lvl=notice_display&id=27971 [artículo] Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications [texto impreso] / Ni A. Khin, Autor ; Yeh Fong Chen, Autor ; Yang Yang, Autor . - 2022 . - pp. 464-472. Idioma : Inglés (eng) Idioma original : Inglés (eng) in The Journal of Clinical Psychiatry > Año 2011 - Vol.72 - No. 4 (Abril) . - pp. 464-472 Palabras clave: Antidepresivos, Trastorno depresivo mayor, Aprobación de medicamentos, Efecto placebo, Ensayos controlados aleatorios. Resumen: There has been concern about a high rate of placebo response and a substantial failure rate in recent clinical trials in major depressive disorder (MDD). This report explores differences in efficacy data from placebo-controlled MDD trials submitted in support of new drug applications (NDAs) over a 25-year period. Link: ./index.php?lvl=notice_display&id=27971

Review of maintenance trials for major depressive disorder / Silvana Borges en The Journal of Clinical Psychiatry, Año 2014 - Vol.75 - No.3 (Marzo)

Público ISBD [artículo]  inThe Journal of Clinical Psychiatry > Año 2014 - Vol.75 - No.3 (Marzo) . - pp. 205-214 Título : Review of maintenance trials for major depressive disorder : a 25-year perspective from the US Food and Drug Administration Tipo de documento: texto impreso Autores: Silvana Borges, Autor ; Yeh Fong Chen, Autor ; Thomas P. Laughren, Autor Fecha de publicación: 2022 Artículo en la página: pp. 205-214 Idioma : Inglés (eng) Idioma original : Inglés (eng) Palabras clave: Trastorno depresivo mayor, Ensayos controlados aleatorios, Prevención secundaria, Tratamiento de retención. Resumen: The maintenance efficacy of antidepressants is usually assessed in postmarketing studies with a randomized withdrawal design. This report explores differences in relapse rates, trial characteristics, and success rates in maintenance efficacy studies submitted to the US Food and Drug Administration (FDA) over a 25-year period. Link: ./index.php?lvl=notice_display&id=27804 [artículo] Review of maintenance trials for major depressive disorder : a 25-year perspective from the US Food and Drug Administration [texto impreso] / Silvana Borges, Autor ; Yeh Fong Chen, Autor ; Thomas P. Laughren, Autor . - 2022 . - pp. 205-214. Idioma : Inglés (eng) Idioma original : Inglés (eng) in The Journal of Clinical Psychiatry > Año 2014 - Vol.75 - No.3 (Marzo) . - pp. 205-214 Palabras clave: Trastorno depresivo mayor, Ensayos controlados aleatorios, Prevención secundaria, Tratamiento de retención. Resumen: The maintenance efficacy of antidepressants is usually assessed in postmarketing studies with a randomized withdrawal design. This report explores differences in relapse rates, trial characteristics, and success rates in maintenance efficacy studies submitted to the US Food and Drug Administration (FDA) over a 25-year period. Link: ./index.php?lvl=notice_display&id=27804

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