An observational study in Major Depressive Disorder, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-13.
Sponsored by Emory University · Observational
This study will characterize the mental health consequences of early-life trauma.
This primary goal of this Center is to characterize the neurobiological consequences of early-life trauma. The Center comprises 6 projects that include human subjects. Human subjects are recruited through Project 6.
Project 2: Psychoimmunology (PI A.H. Miller) Project 4: A Model of Learned Safety(PI: M. Davis) Project 6: Clinical Psychobiology(PI: C. Heim) Project 7: Children of Depressed Mothers(PI: Z. Stowe) Project 8: Functional Brain Imaging (PIs: H.S. Mayberg, G. Berns) Project 9: Structural \& Anatomical Connectivity Studies (PI: C.Kilts, X. Hu).
Project 2: The study seeks to examine the impact of psychosocial stress on neuroendocrine and immune signaling pathways of adult men and women with and without major depression who have experienced serious trauma (abuse, loss) during development. Serial blood samples will be collected at baseline and after an acute speech/math stressor (see Project 6). Assessments include IL-1alpha, and beta, IL-6, TNF alpha as well as DNS binding of relevant neuroendocrine-immune transcription factors, i.e. GR, CREB, and NFkB.
Project 4: This study uses a model of that allows for the independent evaluation of excitation and inhibition of fear-conditioning measured with the acoustic startle reflex. In addition, a dark-enhanced startle paradigm will be used that tests for anxiety. The effects of early-life stress will be evaluated in humans with and without major depressive disorder.
Project 6: This study assesses neuroendocrine and autonomic responses to stress and pharmacological challenge in subjects with and without major depression who have or have nor experienced early life stress. We seek to identify causes of variability in neuroendocrine-autonomic outcome after early life stress. To achieve this principle aim, we study the role of moderating and mediating factors including gender, genotype, type/timing of childhood trauma, as well as the role of adulthood trauma, comorbidity and cognitive dysfunction. The projects serves as a human subjects core for the other projects.
Project 7: This project characterizes effects of maternal depression on offspring in a longitudinal study. Women with and without depression will be prospectively followed through pregnancy and the first 6 months post-partum. Maternal stress and psychopathology, pregnancy and birth complications, medications and infants' physiological and behavioral stress responses will be assessed.
Project 8: This study uses PET and fMRI to characterize the impact of early-life stress on functional neural pathways mediating mood reactivity, self reference and reward-processing in patients with major depression. Cortical-limbic-striatal changes in cases with early stress but no psychopathology that define vulnerability to depression are also identified.
Project 9: This Project uses data obtained in Project 8 as well as diffusion tensor imaging to define the influence of early-life trauma on brain anatomical and functional connectivity.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 113 is below the median of 150 across 653 observational studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will include participants who have experienced early-life trauma.
Exclusion Criteria:
Participants who have experienced early-life trauma will undergo a series of diagnostic tests.
Drug: DEX-CRF stimulation test · Behavioral: Psychosocial stress induction · Procedure: Brain imaging of sad mood , self-reference, reward · Behavioral: Acoustic startle
1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion
Laboratory stress induction, no drug administration
Brain imaging
No drugs involved
Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests
Time frame: Measured at Day 2.5
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Emory University