Efficacy of Agomelatine Versus Duloxetine in Depressed Patients

• Research type

  Research Study

• Full title

  Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder. A randomised, double-blind, international, multicentre study with parallel groups versus duloxetine (60 mg/day). Twenty-four weeks of treatment.

• IRAS ID

  10040

• Sponsor organisation

  Institut de Recherches Internationales Servier (IRIS)

• Eudract number

  2008-004642-92

• ISRCTN Number

  96725312

• Research summary

  There are a number of treatments available for treating depression. New treatments are still required however because none of the current treatments are ideal. Each new treatment that is developed must prove its worth compared with standard treatments. One way of doing this is to compare treatments with one another in clinical trials. The information from such trials can help doctors and patients decide on the best treatment. This study will compare a new treatment with a standard antidepressant. The study will compare the effects of the new treatment and the standard one over a six month period, on:- severity of depression;- sleep (because depression itself and many antidepressants can disrupt sleep);- social functioning (in other words, how depression and treatment affect work, social and family life);- sexual function (because depression itself and many antidepressants can disrupt sexual function);- treatment side effects;- quality of life (a measure of how well a person is overall). During the study, participants will attend 13 scheduled study visits. At these visits the main information for the study will obtained via patient interviews and questionnaires. Participants will be randomly assigned to treatment with the new treatment or the standard one. So that the results of the study are unbiased, neither the participants nor their doctors will know what treatment they have been assigned to.The study is funded by an international pharmaceutical company. It will be conducted at several sites in the UK and around 9 other countries. Around 400 participants will be treated in this study.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  09/H0711/15

• Date of REC Opinion

  11 Mar 2009

• REC opinion

  Further Information Favourable Opinion