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AXS-05 · TARGET

An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

Ensayo de Axsome Therapeutics, Inc. en Trastorno Depresivo Mayor · Depresion resistente al tratamiento.

Más ensayos de: Trastorno depresivo mayor · Depresión resistente al tratamiento.

Fase

Fase 2

Estado

Sin noticias del promotor

Participantes

312

previstos

Centros

1

Fin del objetivo primario

jul 2021

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en abr 2021.

Qué mide

Puntuacion total de la Escala de Calificacion de Depresion de Montgomery-Åsberg (MADRS) (Change from Baseline to Week 6) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode. The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.

Más ensayos de AXSM

Todos los de AXSM, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04971291), actualizada en jul 2021.