Early Life Stress and Depression: Molecular and Functional Imaging Study

This observational study is looking into how difficult experiences in childhood might affect the brain and lead to depression later in life. Researchers want to understand why some people develop mental health issues after childhood adversity, while others remain resilient. They will use different types of brain imaging (functional, structural, and molecular imaging) to look for changes in the brain, specifically focusing on "immuno-oxidative abnormalities" (imbalances in the body's immune response and harmful molecules). The study is recruiting women between 20 and 32 years old who are currently not taking medication. The goal is to better understand these brain changes to help identify people at risk and develop more effective treatments.

Study design
This is an observational study with a planned enrollment of 160 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Immuno-oxidative abnormalities will be measured at baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04713722

Early Life Stress and Depression: Molecular and Functional Imaging

Recruiting
Not specifiedAges 20–32Observational
Mclean Hospital
~160 participants
Updated 2025-12-12 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immuno-oxidative abnormalities
Measured over Baseline
Depression
Trauma, Psychological
1 sites across 1 states
Massachusetts1
  • Diego Pizzagalli, PhD · PRINCIPAL_INVESTIGATOR · Mclean Hospital

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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)

Exclusion

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
Any history of significant head injury or concussion
Past/current DSM-5 diagnosis of: OCD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders NOS, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, autism or any other pervasive developmental disorder, organic mental disorder, anorexia, binge eating disorder or bulimia (however a history of bulimia or binge eating disorder is allowable if it has been in remission for at least two years)
History of moderate or severe substance or alcohol use disorder; or, mild substance or alcohol use disorder within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion).
History of ECT
Patient is clinically unstable, in the judgment of the clinician
  • Immuno-oxidative abnormalitiesBaseline

    Redox ratio and glutamate metabolites in the prefrontal cortex