Related Experiment Video
Updated: Aug 12, 2026
Design and Implementation of an fMRI Study Examining Thought Suppression in Young Women with, and At-risk, for Depression
Published on: May 19, 2015
How does the threshold score to enter a major depression trial influence the size of the available patient population
C J Hawley1, T M Gale, T Sivakumaran
1Department of Psychiatry, QEII Hospital, Welwyn Garden City, UK. c.l.hawley@herts.ac.uk
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 MADRS. A Score To Enter (STE) of > or = 17 on the HAM-D 17-item scale is a typical value, although higher values (i.e. > or = 22 or even > or = 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.
