Protocol for the THREAD (THREshold for AntiDepressants) study: a randomised controlled trial to determine the clinical and cost-effectiveness of antidepressants plus supportive care, versus supportive care alone, for mild to moderate depression in UK general practice
Chatwin, Judy, Kendrick, Tony and Moore, M. (2007) Protocol for the THREAD (THREshold for AntiDepressants) study: a randomised controlled trial to determine the clinical and cost-effectiveness of antidepressants plus supportive care, versus supportive care alone, for mild to moderate depression in UK general practice. BMC Family Practice, 8, (2), 1-9. (doi:10.1186/1471-2296-8-2)
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Official URL: http://dx.doi.org/10.1186/1471-2296-8-2
Description/Abstract
Background: Depression guidelines in the UK recommended a policy of watchful waiting for mild
depression due to a lack of evidence for the effectiveness of antidepressant treatment for mild
cases. However there has been relatively little research carried out in primary care to help establish
the severity threshold at which antidepressant treatment is effective and cost-effective.
Methods/Design: The THREAD (THREshold for AntiDepressants) study is a multi-centre
randomised controlled trial designed to determine the clinical and cost effectiveness of a selective
serotonin reuptake inhibitor (SSRI) plus general practitioner (GP) supportive care, versus
supportive care alone, for mild to moderate depression in primary care. The aim is to recruit 300
patients from three centres (Southampton, London and Liverpool). Depressive symptoms will be
assessed at baseline, 12 weeks and 26 weeks, using the 17-item Hamilton Depression Rating Scale
(HDRS). Two severity sub-groups of patients will be recruited, with HDRS scores of 12–15, and
16–19. Possible predictors of response will be explored including life events and difficulties and
alcohol consumption. Analysis of covariance, controlling for baseline value, severity group and
centre will be used to estimate the overall treatment effectiveness (difference in HDRS score) at
final follow up. The primary analysis will be by 'intention to treat' using double sided tests. The
interaction between severity sub-group and treatment will be tested, and if appropriate, effects
within separate severity sub-groups estimated. The economic analysis will compare the two
treatment groups in terms of mean costs and cost-effectiveness.
Discussion: The results of this study will give GPs important information to help them determine
the severity of depression at which antidepressant treatment is likely to be cost-effective.
| Item Type: | Article |
|---|---|
| ISSN: | 1471-2296 (print) |
| Uncontrolled Keywords: | alcohol, research support, health, depression, patients, london, treatment outcome, economics, analysis, guidelines, treatment, therapy, cost-benefit analysis, humans, antidepressive agents |
| Related URLs: | http://www.biomedcentral.com/1...1-2296/8/2 http://dx.doi.org/10.1186/1471-2296-8-2 |
| Subjects: | R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry R Medicine > RM Therapeutics. Pharmacology |
| Divisions: | University Structure - Pre August 2011 > School of Health Sciences University Structure - Pre August 2011 > School of Medicine > Community Clinical Sciences |
| ePrint ID: | 61708 |
| URI: | http://eprints.soton.ac.uk/id/eprint/61708 |
| Deposited On: | 09 Sep 2008 |
| Last Modified: | 01 Jun 2011 01:44 |
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