Prevalence of Subthreshold Hypomania and Impact on Internal Validity of RCTs for Major Depressive Disorder: Results From a National Epidemiological Sample.

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

Filed under: Depression Treatment

PLoS One. 2013; 8(2): e55448
Hoertel N, Le Strat Y, Limosin F, Dubertret C, Gorwood P

Growing evidence supports the validity of distinguishing major depressive disorder (MDD) plus a lifetime history of subthreshold hypomania (D(m)) from pure MDD in psychiatric classifications. The present study sought to estimate the proportion of individuals with D(m) 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.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 D(m) 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.We found that more than 7 out of ten participants with pure MDD and with D(m) would have been excluded by at least one classical eligibility criterion. Prevalence rate of individuals with D(m) 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.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.
HubMed – depression


Genotype-Based Ancestral Background Consistently Predicts Efficacy and Side Effects across Treatments in CATIE and STAR*D.

Filed under: Depression Treatment

PLoS One. 2013; 8(2): e55239
Adkins DE, Souza RP, Aberg K, Clark SL, McClay JL, Sullivan PF, van den Oord EJ

Only a subset of patients will typically respond to any given prescribed drug. The time it takes clinicians to declare a treatment ineffective leaves the patient in an impaired state and at unnecessary risk for adverse drug effects. Thus, diagnostic tests robustly predicting the most effective and safe medication for each patient prior to starting pharmacotherapy would have tremendous clinical value. In this article, we evaluated the use of genetic markers to estimate ancestry as a predictive component of such diagnostic tests. We first estimated each patient’s unique mosaic of ancestral backgrounds using genome-wide SNP data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) (n?=?765) and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) (n?=?1892). Next, we performed multiple regression analyses to estimate the predictive power of these ancestral dimensions. For 136/89 treatment-outcome combinations tested in CATIE/STAR*D, results indicated 1.67/1.84 times higher median test statistics than expected under the null hypothesis assuming no predictive power (p<0.01, both samples). Thus, ancestry showed robust and pervasive correlations with drug efficacy and side effects in both CATIE and STAR*D. Comparison of the marginal predictive power of MDS ancestral dimensions and self-reported race indicated significant improvements to model fit with the inclusion of MDS dimensions, but mixed evidence for self-reported race. Knowledge of each patient's unique mosaic of ancestral backgrounds provides a potent immediate starting point for developing algorithms identifying the most effective and safe medication for a wide variety of drug-treatment response combinations. As relatively few new psychiatric drugs are currently under development, such personalized medicine offers a promising approach toward optimizing pharmacotherapy for psychiatric conditions. HubMed – depression


Racial/ethnic differences in the prevalence of internalizing symptoms: Do Latin-American immigrant show more symptomatology than Spanish native-born adolescents?

Filed under: Depression Treatment

J Health Psychol. 2013 Feb 12;
Romero-Acosta K, Penelo E, Noorian Z, Ferreira E, Domènech-Llaberia E

This study mainly compared the prevalence of internalizing symptoms of 834 Spanish and 159 Latin-American immigrant adolescents. Participants completed self-report measures about depression, anxiety and somatic symptoms and a socio-demographic questionnaire. The results indicated that being Latin-American was associated with higher levels of depressive symptoms and being female was related to higher depressive and anxiety symptoms. Gender differences were more prevalent in Spaniards than in Latinos, with girls showing more symptoms than boys. High socio-economic status was negatively related to depressive symptoms and anxiety. The results may alert clinicians of the importance of assessing depressive symptoms in Latino adolescents in order to treat this group of youths effectively.
HubMed – depression


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