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noYour doctor may choose to do some blood tests including, complete blood count (CBC), fasting blood sugar, thyroid function, routine electrolytes, vitamin B12, folate levels, and liver function tests, to rule out medical causes for depression. 6 COGNITIVE DYSFUNCTION IN DEPRESSION but also improve the efficiency of clinical trials by identifying appropriate candidates for trials and by providing indicators of target engagement and treatment response. â¢ Using experimental model approaches: Experimental model approaches can be helpful for screening and predicting the ef- fects of antidepressant treatments on cognition, said some partic- ipants. For exampleno
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noearly changes in emotional processing (hot cognition) are seen with antidepressant drug treatments, and this is predictive of later therapeutic response. Modeling the disease process in humans may provide answers to questions about the neurobiologic effects of a treatment early in the drug develop- ment process, before billions of dollars have been spent on a treatment that ultimately fails to show efficacy. One experi- mental model discussed at the workshop is already being used by pharmaceutical companies to screen candidate treatments. â¢ Heterogeneity and stratifying study participants: Heterogene- ity presents challenges in developing treatments, and stratifying study participants into subgroups can be beneficial although it limits generalizability, noted various workshop participants. Pa- tients with depression constitute a diverse group in terms of both symptomatology and response to treatment, and these aspects al- so vary with gender and across the lifespan. Moreover, heteroge- neity has a huge impact on clinical trials, creating ânoiseâ that obscures treatment benefits. Several participants discussed dif- ferent approaches to stratification of study participants into sub- groups that could provide clearer answers in trials and enable the identification of interventions appropriate for different sub- groups. â¢ Addressing pseudo-specificity: Pseudo-specificity may be a major roadblock to the design of clinical trials and regulatory approval, recognized many participants. In order for a treatment to be approved for cognitive dysfunction in depression, regula- tors likely will ask for data showing that the drug works only or better in patients with depression-related cognitive impairment as opposed to cognitive impairment in general or depression in the absence of cognitive impairment. â¢ Employing novel trial designs: Novel trial designs could be usefulno
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nosaid some participants. They suggested a number of mod- ifications to existing trial designs, as well as innovative new de- signs such as adaptive trials, which could address some unique PREPUBLICATION COPY: UNCORRECTED PROOFS order generic valium And then there is the problem by which the investigators defined depression. They did not make a diagnosis with a gold standard, semi structured interview, like the Structured Clinical Interview for DSM Disorders (SCID) administered by trained clinicians. Instead, they relied on a rigid simple interview, the Mini International Neuropsychiatry Interview, more like a questionnaire, that was administered by bachelor-level research assistants. This would hardly pass muster with the Food and Drug Administration (FDA). The investigators had available scores on the interview-administered Hamilton Depression Scale (HAM-D), to measure improvementno
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