Early Life Stress and Depression: Molecular and Functional Imaging

NCT04713722 | Recruiting

• 1 other identifier: 2020P001470
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.

Conditions

Depression; Trauma, Psychological

Outcome Measures

Primary Outcomes (1)

• Immuno-oxidative abnormalities

  Redox ratio and glutamate metabolites in the prefrontal cortex

  Baseline

Secondary Outcomes (3)

• Blood oxygen level dependent (BOLD) activation

  Baseline

• Blood oxygen level dependent (BOLD) activation in emotional processing

  Baseline

• Peripheral inflammation

  Baseline

Study Arms (4)

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

MDD

subjects in a current episode of MDD, with no history of childhood adversity

Healthy Control

healthy control subjects, with no history of childhood adversity

Eligibility Criteria

• Age: 20 Years - 32 Years
• Gender Eligibility Details: Only female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls, those with depression (current or remitted), and those with depression and history of childhood adversity

You may qualify if:

• Females of all races and ethnic origins
• Ages from 20 to 32
• Right-handed
• Capable of providing written informed consent
• Currently unmedicated. Note that this criterion applies at enrollment only, and subjects will be informed that they can continue to be in the study if they begin a new medication after enrollment.
• Normal or corrected-to-normal vision and hearing
• Fluency in written and spoken English
• Absence of first-degree relatives with a history of a psychotic disorder or psychotic symptoms; (adopted individuals are eligible to participate but we will probe about family history in case such information is available to the adopted subject)

You may not qualify if:

• Participants with suicidal ideation where continued study participation is deemed unsafe by the study clinician (these participants will be immediately referred to appropriate clinical treatment)
• Pregnant women, or women of childbearing potential who have a positive result on a urine pregnancy test
• Failure to meet MRI safety requirements including but not limited to any metal implants or prostheses that cannot be removed, or exposure to shrapnel
• Claustrophobia or severe anxiety that might impact participation in neuroimaging
• Injury or movement disorder that may make it difficult to lie still in the scanner
• Any current recreational/illicit drug use as assessed by a urine drug test (covering cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)
• Use of drug or herbal supplement for depression (e.g., St. John's Wort or SAMe) of those that could affect stress response
• Use of any medication in the 24 hours prior to the Scanning procedure (including antibiotics, asthma inhalants, pain relievers, antihistamines, or over-the-counter medications).
• Recent use (within 3 weeks) or any medication that affects blood flow or blood pressure, or which is vasodilating/vasoconstricting
• Use of Melatonin within 5 days of the Scanning procedure
• Metformin use in the past 6 months (for either clinical care or as part of research)
• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine (hypothyroidism), neurologic, autoimmune disease (such as Lyme, Crohn's), or hematologic disease
• Current infectious illness (either transient or chronic); Current episode of allergic reaction or asthma
• Hemophilia; Diabetes with poor glucose control; History of chronic migraine (\> 15 days/mo.); History or current diagnosis of dementia
• History of seizure disorder

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Inflammation panel with RNA DNA samples for Peripheral blood mononuclear cells (PBMC) purification

MeSH Terms

Conditions

Depression; Psychological Trauma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Diego Pizzagalli, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliza Brown

CONTACT

617-855-2589; abrown98@mclean.harvard.edu

Emma Palermo

CONTACT

617-855-4412; ehpalermo@mclean.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Harvard Medical School; Director

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)