Characterizing Psychological Consequences of Childhood Trauma

NCT00209105 | Completed DMC

• 4 other identifiers: IRB00021800P50MH058922572-2004DATR A3-NSC
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Child Abuse; Hypothalamic-Pituitary-Adrenal Axis; Brain Imaging; Depression

Outcome Measures

Primary Outcomes (1)

• Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests

  Measured at Day 2.5

Study Arms (1)

1

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

Interventions

DEX-CRF stimulation test DRUG

1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion

1

Psychosocial stress induction BEHAVIORAL

Laboratory stress induction, no drug administration

1

Brain imaging of sad mood , self-reference, reward PROCEDURE

Brain imaging

1

Acoustic startle BEHAVIORAL

No drugs involved

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

General Clinical Research Center at Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Becky Kinkead, PhD

  Emory University SOM - Dept. of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocate Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2011
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (1)