Trial Profile
An Open-label, Long-Term Extension Study to Assess the Safety and Efficacy of Lu AA21004 in Patients With Major Depressive Disorder (Extension to Lu AA21004/CCT-003 Study)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 23 Sep 2019
Price :
$35
*
At a glance
- Drugs Vortioxetine (Primary)
- Indications Major depressive disorder
- Focus Adverse reactions; Registrational
- Sponsors Takeda
- 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.
- 12 Nov 2017 Results of a short-term study (NCT01355081) and its long-term extension study (NCT01395147), published in the Psychiatry and Clinical Neurosciences Journal.