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A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction

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Trial Profile

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake Inhibitor-Induced Sexual Dysfunction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Vortioxetine (Primary) ; Escitalopram
  • Indications Major depressive disorder; Sexual function disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 22 Oct 2018 According to a Takeda media release, the U.S. Food and Drug Administration has approved a supplemental new drug application (sNDA) for TRINTELLIX (vortioxetine).The TRINTELLIX U.S. labeling now includes data from this study that demonstrated superiority to a commonly-used selective serotonin reuptake inhibitor (SSRI), Lexapro (escitalopram) in improving treatment-emergent sexual dysfunction (TESD).
  • 20 May 2015 Results presented at the 168th Annual Meeting of the American Psychiatric Association.
  • 21 Oct 2014 Primary endpoint (Change in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8) has been met according to results presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.

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