Study of Lu AA21004 in the Treatment of Major Depressive Disorder

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of 3 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

• Sponsor organisation

  Takeda Global Research and Development Centre (Europe) Ltd

• Eudract number

  2008-001580-11

• 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 alifetime 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 a multicentre study investigating the effectiveness and safety of 3 fixed doses of LuAA21004. Approximately 560 patients will be involved from about 70 sites across Europe, Asia, Australia and South Africa.Participants will be in the study for about 13 weeks which will involve a 1 week Screening Period, an 8 week Treatment Period and a 4 week Follow-up Period. After the screening period eligible participants will be randomised (assigned by chance) to receive one of the 3 fixed doses of the study drug or a placebo (dummy drug which contains no active ingredient). Neither the study doctor or the participants will know which group the participants are in. During the Treatment Period various study procedures will be performed. At the end of the study participants may be offered the option to participate in a long-term extension study with Lu AA21004.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/4

• Date of REC Opinion

  9 Apr 2009

• REC opinion

  Further Information Favourable Opinion