dc.contributor.author | Hawley, C. | |
dc.contributor.author | Gale, T.M. | |
dc.contributor.author | Sivakumaran, T. | |
dc.date.accessioned | 2010-02-10T10:25:27Z | |
dc.date.available | 2010-02-10T10:25:27Z | |
dc.date.issued | 2002 | |
dc.identifier.citation | Hawley , C , Gale , T M & Sivakumaran , T 2002 , ' How does the threshold score to enter a major depression trial influence the size of the available patient population for study? ' , Journal of Affective Disorders , vol. 71 , no. 1-3 , pp. 181-187 . https://doi.org/10.1016/S0165-0327(00)00369-4 | |
dc.identifier.issn | 0165-0327 | |
dc.identifier.other | dspace: 2299/4243 | |
dc.identifier.uri | http://hdl.handle.net/2299/4243 | |
dc.description | Original article can be found at: http://www.sciencedirect.com/science/journal/01650327 Copyright Elsevier Inc. [Full text of this article is not available in the UHRA] | |
dc.description.abstract | Background: This paper describes the relationship between entry criteria and eligible population for inclusion in Major Depression (MD) clinical trials. Inclusion criteria for a MD study typically require patients to pass a threshold score on a depression rating scale, most commonly the HAM-D or MÅDRS. A Score To Enter (STE) of ≥17 on the HAM-D 17-item scale is a typical value, although higher values (i.e. ≥22 or even ≥25 points) are often used. It is commonly supposed that patients with higher baseline scores form a more sensitive sample for discriminating active drug from placebo. Method: We present data from a sample of depressed hospital outpatients and describe their general characteristics. We then introduce a model, based upon this sample, which predicts the impact of STE on eligible trial population. Results and conclusion: A small increase in STE has a marked effect on eligible population: an increase in HAM-D (17 item) STE from 17 to 21 and 25 reduces the eligible population by 42 and 76%, respectively. These predictions are reasonably robust when our model is validated with known clinical trial data. Clinical relevance: Our findings have major implications for planning and managing Major Depression trials as higher STEs substantially restrict the proportion of patient eligible for study. | en |
dc.language.iso | eng | |
dc.relation.ispartof | Journal of Affective Disorders | |
dc.title | How does the threshold score to enter a major depression trial influence the size of the available patient population for study? | en |
dc.contributor.institution | Department of Psychology | |
dc.description.status | Peer reviewed | |
rioxxterms.versionofrecord | 10.1016/S0165-0327(00)00369-4 | |
rioxxterms.type | Journal Article/Review | |
herts.preservation.rarelyaccessed | true | |