Major Depressive Disorder Clinical Trial
Official title:
Emory Conte Center for the Neuroscience of Mental Disorders: Psychobiology of Childhood Trauma
Verified date | November 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
This study will characterize the mental health consequences of early-life trauma.
Status | Completed |
Enrollment | 113 |
Est. completion date | March 2011 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | General Clinical Research Center at Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests | Measured at Day 2.5 | No |
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