Prevalence of Subthreshold Hypomania and Impact on Internal Validity of RCTs for Major Depressive Disorder: Results from a National Epidemiological SampleReportar como inadecuado




Prevalence of Subthreshold Hypomania and Impact on Internal Validity of RCTs for Major Depressive Disorder: Results from a National Epidemiological Sample - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Background

Growing evidence supports the validity of distinguishing major depressive disorder MDD plus a lifetime history of subthreshold hypomania Dm from pure MDD in psychiatric classifications. The present study sought to estimate the proportion of individuals with Dm that would have been included in RCTs for MDD using typical eligibility criteria, and examine the potential impact of including these participants on internal validity.

Methods

Data were derived from the 2001–2002 National Epidemiological Survey on Alcohol and Related Conditions NESARC, a national representative sample of 43,093 adults of the United States population. We examined the proportion of participants with a current diagnosis of pure MDD and Dm that would have been eligible in clinical trials for MDD with a traditional set of eligibility criteria, and compared it with that of participants with bipolar 2 disorder if the same set of eligibility criteria was applied. We considered 4 models including different definitions of subthreshold hypomania.

Results

We found that more than 7 out of ten participants with pure MDD and with Dm would have been excluded by at least one classical eligibility criterion. Prevalence rate of individuals with Dm in RCTs for MDD with traditional eligibility criteria would have ranged from 7.98% to 22.59%. Overall exclusion rate of individuals with MDD plus at least 4 lifetime concomitant hypomanic probes significantly differ from those with pure MDD, whereas it was not significantly different in those with at least 2 lifetime concomitant hypomanic probes compared to those with bipolar 2 disorder.

Conclusions

The current design of clinical trials for MDD may suffer from impaired external validity and potential impaired internal validity, due to the inclusion of a substantial proportion of individuals with subthreshold hypomania presenting with similar pattern of exclusion rates to those with bipolar 2 disorder, possibly resulting in a selection bias.



Autor: Nicolas Hoertel , Yann Le Strat, Frédéric Limosin, Caroline Dubertret, Philip Gorwood

Fuente: http://plos.srce.hr/



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