Early Life Stress and Depression: Molecular and Functional Imaging (ELS)
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|ClinicalTrials.gov Identifier: NCT04713722|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : February 21, 2021
|Condition or disease|
|Depression Trauma, Psychological|
Epidemiological studies have shown that severe childhood adversity explains 32-44% of psychiatric disorders, and is associated with 4.6-fold risk for MDD later in life. In spite of these epidemiological data, the neurobiological underpinnings associated with maladaptive sequelae of severe childhood adversity as well as resilience remain largely unknown.
Preclinical research suggests that early adversity leads to (1) structural abnormalities in brain regions critically implicated in stress regulation; (2) increased oxidative stress; and (3) glutamatergic abnormalities. The current research protocol is designed to prospectively test the contributions of these abnormalities in individuals exposed to severe childhood adversity.
Improving our understanding of neurobiological mechanisms associated with different childhood adversity outcomes is of paramount importance in order to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Early Life Stress and Depression: Molecular and Functional Imaging|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||April 1, 2025|
|Estimated Study Completion Date :||April 1, 2025|
MDD/childhood adversity group
subjects with current MDD who experienced childhood adversity
rMDD/ childhood adversity
subjects with a history of MDD who experienced childhood adversity
subjects in a current episode of MDD, with no history of childhood adversity
healthy control subjects, with no history of childhood adversity
- Immuno-oxidative abnormalities [ Time Frame: Baseline ]Redox ratio and glutamate metabolites in the prefrontal cortex
- Blood oxygen level dependent (BOLD) activation [ Time Frame: Baseline ]Prefrontal cortex activation during a reward task
- Blood oxygen level dependent (BOLD) activation in emotional processing [ Time Frame: Baseline ]Prefrontal cortex activation during an emotional processing task
- Peripheral inflammation [ Time Frame: Baseline ]Stress-related pro-inflammatory transcription control pathways
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713722
|Contact: Diego Pizzagalli, PhD||(617) firstname.lastname@example.org|
|Contact: David Crowley, ALMemail@example.com|
|Principal Investigator:||Diego Pizzagalli, PhD||Mclean Hospital|