An observational study in Major Depressive Disorder and Anxiety Disorders, sponsored by University of Texas at Austin. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-20.
Sponsored by University of Texas at Austin · Observational
The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.
Depression vulnerability has been linked to certain variants of the serotonin transporter gene. Research indicates that a polymorphism of the serotonin transporter (5-HTTLPR) gene appears to moderate the association between life stress and depression onset. Life stress robustly predicts depression onset for individuals with two short 5-HTTLPR alleles. Individuals homozygous for the short 5-HTTLPR allele thus appear to be more sensitive to the effect of life stress, which in turn contributes to depression onset. A recent study showed that short allele carriers presented with a threat (social or other threats) who also had high levels of testosterone had elevated cortisol after exposure to the threat. There is neurobiological evidence that short allele status, elevated testosterone levels, and elevated cortisol levels are all linked to amygdala hyper-reactivity to the same classes of environmental threats. Thus, this study will test, for the first time, a potential interaction between 5-HTTLPR status and experimentally manipulated cortisol levels as risk factors for downstream mood and/or anxiety disorders by examining potential dysregulated stress responses among short allele carriers who have elevated cortisol levels.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 120 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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University of Texas at Austin students
Exclusion Criteria:
Control group who will not receive hydrocortisone. Will act as a comparison group to the hydrocortisone group.
Group will receive 20mg oral hydrocortisone
Drug: Hydrocortisone
Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.
Also known as: Cortef, Cortisol, Hydrocortone
Change in testosterone concentration
Subjects will be administered hydrocortisone or placebo. One hour after administration, they will be exposed to an environmental threat manipulation. 20 minutes after this manipulation, saliva will be collected, and testosterone concentrations will be assessed and compared to pre-manipulation concentrations
Time frame: 2 hours post hydrocortisone administration
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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University of Texas at Austin