Recruiting

Observational Study

Sponsor:

Mclean Hospital

Code:

NCT04713722

Conditions

Depression

Trauma, Psychological

Eligibility Criteria

Sex: Female

Age: 20 - 32

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04713722

Start date

Feb 1, 2021

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 32

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Immuno-oxidative abnormalities [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Aliza Brown

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

Emma Palermo

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

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

David Crowley

617-855-4432djcrowley@mclean.harvard.edu

Principal Investigator:

Diego Pizzagalli, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2025-12-12.