Brexpiprazole in elderly patients with major depressive disorder

• Research type

  Research Study

• Full title

  Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of brexpiprazole (1 and 3 mg/day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to anti-depressant treatment

• IRAS ID

  129843

• Sponsor organisation

  H.Lundbeck A/S

• Eudract number

  2012-001361-32

• Research summary

  Depression is a serious chronic illness that is characterised by a wide range of emotional and physical symptoms. Symptoms of depression in the elderly differ to those in a younger person. Some of the symptoms in depression in the elderly can consist of unexplained physical problems i.e. rashes or nausea and also may include behavioural symptoms, cognitive disturbance, thoughts of death, anxiety, irritability, nervousness and abnormalities of motor function. Currently elderly patients suffering from depression are usually treated with a marketed anti-depressant 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 treatment with placebo (identical-looking inactive drug) can help improve the symptoms of depression in elderly patients who have not adequately responded to previous treatment with anti-depressants.

  Approximately 1334 patients, aged ≥65, will be enrolled onto this study across 14 countries at 130 sites, 4 sites will be in the UK. The study duration is 24 weeks; from start of treatment to final follow-up, with a screening period of up to 28 days beforehand. Patients will be allocated randomly (like flipping a coin) to receive either brexpiprazole or placebo with a marketed anti-depressant and expected to attend the research site for screening procedures and then 13 monitoring visits over the course of the 24 weeks.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  13/NW/0337

• Date of REC Opinion

  1 Jul 2013

• REC opinion

  Further Information Favourable Opinion