Mirtazapine for treatment resistant depression

Conditions

Depression Mental and Behavioural Disorders Depressive episode, unspecified

David Keßler, Alison Burns, Debbie Tallon, Glyn Lewis, Stephanie MacNeill et al. (16 authors)

Health Technology Assessment2018-11-0130 citations

Mirtazapine added to SSRIs or SNRIs for treatment resistant depression in primary care: phase III randomised placebo controlled trial (MIR)

David Keßler, Stephanie MacNeill, Deborah Tallon, Glyn Lewis, T. J. Peters et al. (19 authors)

BMJ2018-10-3178 citations

10.1136/bmj.k4218

Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): study protocol for a randomised controlled trial.

Tallon D, Wiles N, Campbell J, Chew-Graham C, Dickens C, Macleod U, Peters TJ, Lewis G, Anderson IM, Gilbody S, Hollingworth W, Davies S, Kessler D.

2016-02-038 citations

10.1186/s13063-016-1199-2

Interventions

The addition of Mirtazapine to SSRI antidepressants Added 27/07/2017: To investigate whether combining mirtazapine with Serotonin-Noradrenaline Reuptake Inhibitor (SNR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years 2. Currently taking any of the following SSRI or SNRI antidepressants, for at least 6 weeks at recommended (BNF) doses: 2.1. Fluoxetine 2.2. Sertraline 2.3. Citalopram 2.4. Escitalopram 2.5. Fluvoxamine 2.6. Paroxetine 2.7. Duloxetine 2.8. Venlafaxine and who have done so for at least 6 weeks at 3. Patients who score 14 or more on the Beck Depression Inventory (BDI) 4. Patients who have adhered to their medication and meet ICD-10 criteria for depression (assessed using the Computerised Interview Schedule ? Revised version (CIS-R))

Exclusion criteria

Exclusion criteria: GPs will be asked to exclude patients who have bipolar disorder, psychosis or alcohol/substance abuse/dependence or who are pregnant. In addition, we will exclude patients who: are not able to complete the study questionnaires or have a past history of an adverse reaction to mirtazapine.

Design outcomes

Primary

Measure	Time frame
Change in Beck Depression Inventory score at 12 weeks (added 27/07/2017: measured using the BDI-I) measured as a continuous variable	—

Secondary

Measure	Time frame
Current secondary outcome measures: The following are measured at 12, 24, and 52 weeks: 1. Response 2. Remission of depression symptoms 3. Changes in anxiety symptoms 4. Adverse Effects 5. Quality of life 6. Adherence to antidepressant medication 7. Health and social care use 8. Time off work 9. Cost effectiveness All outcomes are analysed on an intention to treat basis. Previous secondary outcome measures: 1. 50% improvement in BDI score (remission) 2. A measure of anxiety (GAD7) 3. Quality of life (EQ-5D-5L) 4. Health care utilisation	—

Measure

Time frame

Current secondary outcome measures: The following are measured at 12, 24, and 52 weeks: 1. Response 2. Remission of depression symptoms 3. Changes in anxiety symptoms 4. Adverse Effects 5. Quality of life 6. Adherence to antidepressant medication 7. Health and social care use 8. Time off work 9. Cost effectiveness All outcomes are analysed on an intention to treat basis. Previous secondary outcome measures: 1. 50% improvement in BDI score (remission) 2. A measure of anxiety (GAD7) 3. Quality of life (EQ-5D-5L) 4. Health care utilisation

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Countries

United Kingdom

Outcome results

None listed