Mirtazapine for treatment resistant depression

• Research type

  Research Study

• Full title

  Mirtazapine added to SSRIs for treatment resistant depression in primary care: a placebo controlled randomised controlled trial

• IRAS ID

  116771

• Contact name

  David Kessler

• Sponsor organisation

  University of Bristol

• Eudract number

  2012-000090-23

• ISRCTN Number

  ISRCTN06653773

• Research summary

  Antidepressants are the treatment of choice in primary care for depression, but treatment resistance is common. The current lack of evidence means that clinicians are increasingly faced with a dilemma as to what action to recommend to patients who do not respond to a course of treatment with antidepressants. There are a number of pharmacological strategies for improving response but the evidence base is small. There are good reasons to suppose that mirtazapine, an antidepressant with a complementary mechanism of action to the SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin and noradrenaline reuptake inhibitor), might act in combination with either to improve outcome. There is preliminary evidence from small studies to suggest that this is the case. We propose a large pragmatic, placebo-controlled randomised trial of the combination of mirtazapine with an SSRI or SNRI in depressed patients who have not responded to at least 6 weeks treatment with an SSRI or SNRI, to test this hypothesis. Given the high prevalence of depression in primary care, an effective intervention has the potential to have a substantial impact on the health and economic burden associated with this patient group. Adult patients who have been prescribed SSRI or SNRI antidepressants by their GP for at least 6 weeks will be invited to take part. Consenting patients will be asked to: take the trial medication (randomised allocation of mirtazapine or placebo) for 12 months; complete follow-up questionnaires at 6 weeks, 12 weeks, 24 weeks, and 12 months post-randomisation. A review of primary care notes will be conducted after the 12-month follow-up assessment.

• REC name

  Wales REC 2

• REC reference

  12/WA/0353

• Date of REC Opinion

  25 Jan 2013

• REC opinion

  Further Information Favourable Opinion