Characterizing Psychological Consequences of Childhood Trauma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Becky Kinkead, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00209105
First received: September 13, 2005
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

This study will characterize the mental health consequences of early-life trauma.


Condition Intervention
Major Depressive Disorder
Drug: DEX-CRF stimulation test
Behavioral: Psychosocial stress induction
Procedure: Brain imaging of sad mood , self-reference, reward
Behavioral: Acoustic startle

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Emory Conte Center for the Neuroscience of Mental Disorders: Psychobiology of Childhood Trauma

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests [ Time Frame: Measured at Day 2.5 ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: January 2005
Study Completion Date: March 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants who have experienced early-life trauma will undergo a series of diagnostic tests.
Drug: DEX-CRF stimulation test
1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion
Behavioral: Psychosocial stress induction
Laboratory stress induction, no drug administration
Procedure: Brain imaging of sad mood , self-reference, reward
Brain imaging
Behavioral: Acoustic startle
No drugs involved

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

This study will include participants who have experienced early-life trauma.

Criteria

Inclusion Criteria:

  • For participants assigned to the MDD groups: current DSM-IV diagnosis of MDD
  • For participants assigned to the early-life stress group: repeated (once per month or more for at least year) sexual or physical abuse before the age of 13 years by a perpetrator at least 5 years older at the time
  • For female participants: regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures

Exclusion Criteria:

  • Meets DSM-IV criteria for a gender identity disorder
  • For all participants assigned to non-MDD groups: DSM-IV diagnosis of current MDD
  • For all participants assigned to the group without early-life stress: major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness, or natural disaster
  • Significant medical illness, such as gastrointestinal, neurological, hormonal, heart, lung, kidney, liver, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ECG, and laboratory tests
  • Pregnant or breastfeeding
  • Past or current presence of psychotic symptoms or bipolar disorder
  • Current presence of psychoactive substance abuse/dependency or eating disorders
  • Currently taking hormonal medication
  • Taking psychotropic medication within 4 weeks of study entry
  • General exclusion criteria for PET and fMRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209105

Locations
United States, Georgia
General Clinical Research Center at Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Becky Kinkead, PhD Emory University SOM - Dept. of Psychiatry and Behavioral Sciences
  More Information

No publications provided

Responsible Party: Becky Kinkead, PhD, Assocate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00209105     History of Changes
Other Study ID Numbers: IRB00021800, P50MH058922, 572-2004, DATR A3-NSC
Study First Received: September 13, 2005
Last Updated: November 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Child Abuse
Hypothalamic-Pituitary-Adrenal Axis
Brain Imaging
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014