Format

Send to

Choose Destination
Trials. 2019 Jun 3;20(1):319. doi: 10.1186/s13063-019-3390-8.

A randomised controlled trial assessing the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in primary care patients who are taking long-term maintenance antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): study protocol for a randomised controlled trial.

Author information

1
Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. larisa.duffy@ucl.ac.uk.
2
Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.
3
Research Department of Primary Care and Population Health, University College London, UCL Medical School, Upper 3rd Floor, Royal Free Campus, Rowland Hill Street, London, NW3 2PF, UK.
4
Priment Clinical Trials Unit, University College London, UCL Medical School, Upper 3rd Floor, Royal Free Campus, Rowland Hill Street, London, NW3 2PF, UK.
5
Comprehensive Clinical Trials Unit, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK.
6
Department of Health Sciences, University of York, Seebohm Rowntree Building, Heslington, York, YO10 5DD, UK.
7
Primary Care & Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, SO16 5ST, UK.
8
Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK.
9
Department of Family Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario, L8S 4L8, Canada.
10
Department of General Practice, University of Otago, Christchurch, PO Box 4345, Christchurch, 8140, New Zealand.

Abstract

BACKGROUND:

Antidepressants are used both for treating acute episodes and for prophylaxis to prevent future episodes of depression, also called maintenance treatment. This article describes the protocol for a randomised controlled trial (ANTLER: ANTidepressants to prevent reLapse in dEpRession) to investigate the clinical effectiveness and cost-effectiveness in UK primary care of continuing on long-term maintenance antidepressants compared with a placebo in preventing relapse of depression in those who have taken antidepressants for more than 9 months and who are currently well enough to consider stopping maintenance treatment.

METHODS/DESIGN:

The ANTLER trial is an individually randomised, double-blind, placebo-controlled trial in which participants are randomised to remain on active medication or to take an identical placebo after a tapering period of 2 months. Eligible participants are those who: are between the ages of 18 and 74 years; have had at least two episodes of depression; and have been taking antidepressants for 9 months or more and are currently taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg but are well enough to consider stopping their medication. The participants will be followed up at 6, 12, 26, 39 and 52 weeks. The primary outcome will be the time in weeks to the beginning of the first episode of depression after randomisation. This will be measured using a retrospective version of the Clinical Interview Schedule-Revised administered at 12, 26, 39 and 52 weeks. Secondary outcomes will include depressive and anxiety symptoms, adverse effects, withdrawal symptoms, emotional processing tasks, quality of life and the resources and costs used. We will also perform a cost-effectiveness analysis based on results of the trial.

DISCUSSION:

The ANTLER trial findings will inform primary care prescribing practice by providing a valid and generalisable estimate of the clinical effectiveness and cost-effectiveness of long-term maintenance treatment with antidepressants in UK primary care.

TRIAL REGISTRATION:

Controlled Trials ISRCTN Registry, ISRCTN15969819. Registered on 21 September 2015.

KEYWORDS:

Antidepressants; Citalopram; Depression; Fluoxetine; Mirtazapine; Primary care; Selective serotonin reuptake inhibitors; Sertraline

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center