LuAA21004 v agomelatine in adults with Major Depressive Disorder

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel-group, active-controlled, flexible dose study evaluating the effects of Lu AA21004 versus agomelatine in adult patients suffering from major depressive disorder with inadequate response to antidepressant treatment

• IRAS ID

  88889

• Contact name

  Mark Dale

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2011-002362-21

• Research summary

  Up to half of patients suffering from major depressive disorder (MDD) do not respond to their first prescribed antidepressant, and even fewer of these patients achieve symptom remission. Therefore, there is often a need to modify treatment in order to reduce the risk of relapse and recurrence, and in order to improve long-term outcomes for these patients. The most popular strategy of clinicians is to switch these patients to a non-SSRI (selective serotonin reuptake inhibitor) agent. At present there is very limited data available from randomised controlled trials comparing non-SSRI treatments in patients who did not respond to their first-line antidepressant treatment. In this study we wish to evaluate whether the effect of Lu AA21004 (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) which are both non-SSRI treatments in patients with MDD who were previously unresponsive to SSRI treatment.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0747

• Date of REC Opinion

  3 Jan 2012

• REC opinion

  Further Information Favourable Opinion