2013
DOI: 10.4088/jcp.12m07935
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Generalizability of Clinical Trial Results for Bipolar Disorder to Community Samples

Abstract: Traditional clinical trials tend to exclude a majority of individuals with bipolar disorder. Clinical trials should carefully consider the impact of eligibility criteria on the generalizability of their results and explain the rationale for their use. Future trials should weigh the trade-offs between internal validity and the representativeness of the study.

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Cited by 51 publications
(23 citation statements)
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“…As previously suggested, MDD plus subthreshold hypomania is associated with increased risk for suicide (Angst et al, 2003;Judd and Akiskal, 2003) as well as a greater conversion rate to threshold-level bipolar disorder (Fiedorowicz et al, 2011;Zimmermann et al, 2009). However, results from two large, nationally representative studies reveal a strikingly high prevalence of bipolar disorders in emerging adulthood that appear to resolve substantially during the latter half of the third decade of life (Cicero et al, 2009;Hoertel et al, 2013a). In our study, prevalence rates of suicide attempt was significantly higher in individuals with lifetime D(m) (13.55% vs. 7.72%;OR¼1.87,], po0.001) and non-hierarchical D(m) (13.77% vs. 7.72%;OR¼1.91,], po0.001), compared with those with lifetime pure MDD and non-hierarchical pure MDD respectively.…”
Section: Discussionmentioning
confidence: 92%
See 1 more Smart Citation
“…As previously suggested, MDD plus subthreshold hypomania is associated with increased risk for suicide (Angst et al, 2003;Judd and Akiskal, 2003) as well as a greater conversion rate to threshold-level bipolar disorder (Fiedorowicz et al, 2011;Zimmermann et al, 2009). However, results from two large, nationally representative studies reveal a strikingly high prevalence of bipolar disorders in emerging adulthood that appear to resolve substantially during the latter half of the third decade of life (Cicero et al, 2009;Hoertel et al, 2013a). In our study, prevalence rates of suicide attempt was significantly higher in individuals with lifetime D(m) (13.55% vs. 7.72%;OR¼1.87,], po0.001) and non-hierarchical D(m) (13.77% vs. 7.72%;OR¼1.91,], po0.001), compared with those with lifetime pure MDD and non-hierarchical pure MDD respectively.…”
Section: Discussionmentioning
confidence: 92%
“…Third, severity and clinical significance of major depressive disorder are determined by the AUDADIS-IV at the syndromal rather than symptom level (Hoertel et al, 2013a).…”
Section: Discussionmentioning
confidence: 99%
“…They include severity of major depression (Sargeant et al, 1990; Skodol et al, 2011; Spijker et al, 2010; Steinert et al, 2014), number of lifetime MDEs (Skodol et al, 2011; Spijker et al, 2010, Steinert et al, 2014), co-occurring Axis I (Hoertel et al, 2013a, 2013b, 2013c; Keller et al, 1982, 1992; Klein et al, 2006; Manetti et al, 2014; Steinert et al, 2014) and Axis II disorders (Grilo et al, 2005; Skodol et al, 2011), history of suicide attempts (Avery and Winokur, 1978), family history of depression (Patten et al, 2010), concurrent physical health problems and psychosocial difficulties (Lam et al, 2009), early age at onset of first MDE (Hoertel et al, 2013a; Klein et al, 1999), stressful live events (Wang et al, 2012), female gender, older age and being divorced or widowed (Colman et al, 2011; Dowrick et al, 2011; Fava et al, 2007; Gilman et al, 2013; Hardeveld et al, 2013a, 2013b; Kornstein et al, 2000; Lam et al, 2009; Patten et al, 2012; ten Doesschate et al, 2010; Wang et al, 2012). …”
Section: Introductionmentioning
confidence: 99%
“…Only one study, conducted in a clinical sample, [8] controlled for overall depression severity between groups, but its results may not be applicable to women in the general population. [35, 36] …”
mentioning
confidence: 99%