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How does the threshold score to enter a major depression trial influence the size of the available patient population for study? / Hawley, C.; Gale, T.M.; Sivakumaran, T.

In: Journal of Affective Disorders, Vol. 71, No. 1-3, 2002, p. 181-187.

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@article{68e862edbf804a0f8ad6ba4b1dde0be1,
title = "How does the threshold score to enter a major depression trial influence the size of the available patient population for study?",
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 M{\AA}DRS. 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.",
author = "C. Hawley and T.M. Gale and T. Sivakumaran",
note = "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]",
year = "2002",
doi = "10.1016/S0165-0327(00)00369-4",
language = "English",
volume = "71",
pages = "181--187",
journal = "Journal of Affective Disorders",
issn = "0165-0327",
publisher = "Elsevier",
number = "1-3",

}

RIS

TY - JOUR

T1 - How does the threshold score to enter a major depression trial influence the size of the available patient population for study?

AU - Hawley, C.

AU - Gale, T.M.

AU - Sivakumaran, T.

N1 - 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]

PY - 2002

Y1 - 2002

N2 - 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.

AB - 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.

U2 - 10.1016/S0165-0327(00)00369-4

DO - 10.1016/S0165-0327(00)00369-4

M3 - Article

VL - 71

SP - 181

EP - 187

JO - Journal of Affective Disorders

JF - Journal of Affective Disorders

SN - 0165-0327

IS - 1-3

ER -