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.
Adult
Aged
Antidepressive Agents
/ adverse effects
Citalopram
/ therapeutic use
Cost-Benefit Analysis
Depression
/ prevention & control
Double-Blind Method
Fluoxetine
/ therapeutic use
Humans
Middle Aged
Mirtazapine
/ therapeutic use
Outcome Assessment, Health Care
Primary Health Care
Randomized Controlled Trials as Topic
Recurrence
Retrospective Studies
Sample Size
Sertraline
/ therapeutic use
Antidepressants
Citalopram
Depression
Fluoxetine
Mirtazapine
Primary care
Selective serotonin reuptake inhibitors
Sertraline
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
03 Jun 2019
03 Jun 2019
Historique:
received:
07
12
2018
accepted:
02
05
2019
entrez:
5
6
2019
pubmed:
5
6
2019
medline:
21
12
2019
Statut:
epublish
Résumé
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. 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. 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. Controlled Trials ISRCTN Registry, ISRCTN15969819. Registered on 21 September 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
Controlled Trials ISRCTN Registry, ISRCTN15969819. Registered on 21 September 2015.
Identifiants
pubmed: 31159856
doi: 10.1186/s13063-019-3390-8
pii: 10.1186/s13063-019-3390-8
pmc: PMC6547591
doi:
Substances chimiques
Antidepressive Agents
0
Fluoxetine
01K63SUP8D
Citalopram
0DHU5B8D6V
Mirtazapine
A051Q2099Q
Sertraline
QUC7NX6WMB
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
319Subventions
Organisme : Department of Health
ID : HTA/13/115/48
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 13/115/48
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