Mirtazapine for treatment resistant depressio

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Depressive episode, unspecified

• Registration Number: ISRCTN06653773
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

1. 2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26842107 2. 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30381374 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30468145 4. 2018 qualitative study results in https://www.ncbi.nlm.nih.gov/pubmed/30547766

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-20
• Study Completion: 2016-06-30
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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