Major Depressive DisorderNCT00209105
Characterizing Psychological Consequences of Childhood Trauma
An observational study of Major Depressive Disorder, run by Emory University at 1 site in United States.
Trial summary
This study will characterize the mental health consequences of early-life trauma. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- DEX-CRF stimulation test, Psychosocial stress induction and Brain imaging of sad mood , self-reference, reward
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include participants who have experienced early-life trauma.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center at Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Emory Conte Center for the Neuroscience of Mental Disorders: Psychobiology of Childhood Trauma
This study will characterize the mental health consequences of early-life trauma.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- DEX-CRF stimulation test, Psychosocial stress induction, Brain imaging of sad mood , self-reference, reward, Acoustic startle
- Keywords
- Child Abuse, Hypothalamic-Pituitary-Adrenal Axis, Brain Imaging, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEX-CRF stimulation testDrug
1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion
Psychosocial stress inductionBehavioural
Laboratory stress induction, no drug administration
Brain imaging of sad mood , self-reference, rewardProcedure or surgery
Brain imaging
Acoustic startleBehavioural
No drugs involved
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants who have experienced early-life trauma will undergo a series of diagnostic tests. Receives: Drug: DEX-CRF stimulation test; Behavioral: Psychosocial stress induction; Procedure: Brain imaging of sad mood , self-reference, reward; Behavioral: Acoustic startle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests
Measured: Measured at Day 2.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Becky Kinkead, PhD, Emory University
- Investigators
- Becky Kinkead, PhD, Principal investigator, Emory University SOM - Dept. of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209105
- Sponsor's protocol ID
- IRB00021800
- Other IDs
- P50MH058922, 572-2004, DATR A3-NSC
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emory Conte Center for the Neuroscience of Mental Disorders: Psychobiology of Childhood Trauma
- ClinicalTrials.gov ID
- NCT00209105
- Acronym / sponsor ID
- IRB00021800
- Conditions
- Major Depressive Disorder
- Keywords
- Child Abuse, Hypothalamic-Pituitary-Adrenal Axis, Brain Imaging, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will characterize the mental health consequences of early-life trauma.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: DEX-CRF stimulation test, Behavioral: Psychosocial stress induction, Procedure: Brain imaging of sad mood , self-reference, reward, Behavioral: Acoustic startleParticipants who have experienced early-life trauma will undergo a series of diagnostic tests. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include participants who have experienced early-life trauma.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEX-CRF stimulation test1 ug/kg body weight of CRF for determining hpa response post dexamethasone ingestion | Drug | 1 |
| Psychosocial stress inductionLaboratory stress induction, no drug administration | Behavioural | 1 |
| Brain imaging of sad mood , self-reference, rewardBrain imaging | Procedure or surgery | 1 |
| Acoustic startleNo drugs involved | Behavioural | 1 |
Primary outcome
Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests
Time frame: Measured at Day 2.5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Kinkead, PhD principal investigator
Emory University SOM - Dept. of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathophysiological pathways (e.g., blood chemicals, physiological measures, brain images, behavioral measures), as assessed by diagnostic tests (time frame: Measured at Day 2.5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.