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Search / Trial NCT04713722

Early Life Stress and Depression: Molecular and Functional Imaging

Launched by MCLEAN HOSPITAL · Jan 14, 2021

Trial Information

Current as of September 08, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how severe childhood experiences, like trauma or stress, can affect mental health later in life, particularly in women aged 20 to 32. The researchers want to understand the biological changes in the brain linked to these early life stresses, focusing on something called oxidative stress, which relates to how cells in the body handle damage. By using advanced imaging techniques, they aim to uncover why some people develop depression while others remain resilient despite similar hardships.

To participate, women should be right-handed, fluent in English, and able to give written consent. They should not be currently taking any medications for depression and must pass safety checks for MRI scans. Participants can expect to undergo brain imaging while the researchers study the effects of early life stress on their mental health. The trial is actively recruiting, and it’s important for potential participants to know that anyone with serious mental health issues or certain medical conditions may not be eligible.

Gender

FEMALE

Eligibility criteria

  • 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

About Mclean Hospital

McLean Hospital, a leading psychiatric affiliate of Harvard Medical School, is dedicated to advancing mental health care through innovative research and clinical trials. Renowned for its commitment to scientific excellence, McLean harnesses a multidisciplinary approach to address a wide range of psychiatric disorders, including depression, anxiety, and schizophrenia. With state-of-the-art facilities and a team of expert clinicians and researchers, the hospital aims to develop effective treatment strategies and improve patient outcomes. Its robust clinical trial program fosters collaboration and contributes to the broader understanding of mental health, ultimately enhancing therapeutic options for individuals in need.

Locations

Belmont, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Diego Pizzagalli, PhD

Principal Investigator

Mclean Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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