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