Extension Study of Lu AA21004 in Subjects with MDD
Research type
Research Study
Full title
A Long-Term, Open-Label, Flexible-Dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 in Subjects With Major Depressive Disorder
Sponsor organisation
Takeda Global Research and Development Centre (Europe) Ltd
Eudract number
2008-001581-91
Research summary
Depression has been recognised as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder (MDD) is among the most important causes of disability worldwide, in both developing and developed countries. MDD is reported to be the most common mood disorder, with a lifetime prevalence of about 15% in men and as high as 25% in women. Depression is recurrent in 75% to 80% of patients, becomes chronic (ie, lasting 2 years or longer) in 15% to 20% of depressed patients, and can lead to substantial impairments in an individual??s ability to take care of his or her everyday responsibilities. Lu AA21004 is an investigational drug under development by Takeda and H. Lundbeck A/S, for the treatment of MDD and generalised anxiety disorder due to its antidepressant potential. This study, which is being funded by Takeda, is an extension study to a previous study involving Lu AA21004 and has been designed to assess the long-term safety and tolerability of flexible doses of Lu AA21004. Approximately 840 patients will be involved from about 100 sites across North America, Europe, Asia and Australia. Patients who have completed the previous study involving Lu AA21004 will be eligible to receive treatment with Lu AA21004 for 52 weeks. During this time various study procedures will be performed. All participants will start on the same dose of Lu AA21004 which may subsequently be increased or decreased based on the patient's response and tolerability.
REC name
Scotland A REC
REC reference
09/MRE00/5
Date of REC Opinion
9 Apr 2009
REC opinion
Further Information Favourable Opinion