Brexpiprazole in patients with major depressive disorder

• Research type

  Research Study

• Full title

  Interventional, randomised, double-blind, parrallel-group, placebo-controlled, flexible-dose, long term study of brexiprazole as adjunctive treatmenr in patients with major depressive disorder with an inadequate response to antidepressant medication

• IRAS ID

  127972

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2012-001380-76

• Duration of Study in the UK

  2 years, 6 months, 6 days

• Research summary

  Depression is a serious chronic illness that is characterised by a wide range of emotional and physical symptoms. Symptoms of depression can be different for each person. Some of the symptoms are very low mood, loss of pleasure in almost all activities, feelings of worthlessness, guilt or regret, feelings of hopelessness or helplessness, impaired concentration and difficulties performing everyday tasks. Currently patients suffering from depression are usually treated with a marketed antidepressant therapy but not all patients respond sufficiently well to this therapy.

  The aim of this study is to test whether the addition of brexpiprazole to treatment with a marketed antidepressant when compared to addition of a placebo (identical-looking inactive drug) can help improve the symptoms of depression in patients who have not adequately responded to previous treatment with antidepressants.

  Approximately 1400 patients, aged between 18 to 75, will be enrolled onto this study across 12 countries at 100 sites, 5 sites will be in the UK. The study duration is 40 weeks; from start of treatment to final follow-up. Patients will be assigned randomly (like flipping a coin) to receive either brexpiprazole or placebo with a marketed anti-depressant and expected to attend the hospital or research site for screening procedures and then 18 monitoring visits over the course of the 40 weeks.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  13/NW/0270

• Date of REC Opinion

  24 Jun 2013

• REC opinion

  Further Information Favourable Opinion