Trial Profile
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 28 Mar 2023
Price :
$35
*
At a glance
- Drugs Vortioxetine (Primary)
- Indications Major depressive disorder
- Focus Registrational; Therapeutic Use
- Sponsors Takeda; Takeda Global Research and Development Center
- 01 May 2023 Results of pooled analysis from NCT01140906, NCT01153009, NCT01163266, NCT01255787, NCT01488071, published in the Journal of Affective Disorders
- 20 Sep 2019 According to a Takeda media release, based on the data from the pivotal phase III study (NCT02389816) along with data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147), the Ministry of Health, Labour and Welfare (MHLW) has aaproved Trintellix (vortioxetine) for the treatment of Major Depressive Disorder in Adults.
- 28 Sep 2018 According to a Takeda media release, based on the data from the pivotal phase III study (NCT02389816) along with data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147), Lundbeck and its partner Takeda has submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults.