Investigating the link between childhood adversity and depression using brain imaging

Early Life Stress and Depression: Molecular and Functional Imaging

This study looks at how tough experiences in childhood might affect the brain and lead to depression later in life, to help identify who might be at risk and how to better support them.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 20 Years to 32 Years
• Sex: Female
• Sponsor: Mclean Hospital (Academic / other)
• Locations: 1 site (Belmont, Massachusetts)
• Trial ID: NCT04713722 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the neurobiological mechanisms associated with severe childhood adversity and its impact on the development of major depressive disorder (MDD). By utilizing functional, structural, and molecular imaging techniques, the research will examine oxidative stress abnormalities in the brain of individuals who have experienced significant childhood trauma. The study seeks to differentiate between those who develop psychopathology and those who demonstrate resilience despite early adversity. Understanding these mechanisms is crucial for identifying at-risk individuals and developing targeted therapeutic interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are right-handed females aged 20 to 32 who have experienced severe childhood adversity and are currently unmedicated.

Not a fit: Patients with suicidal ideation or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification and treatment strategies for individuals at risk of depression due to childhood adversity.

How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a strong link between childhood adversity and psychiatric disorders, suggesting potential for meaningful insights.

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

Where this trial is running

Belmont, Massachusetts

• McLean Hospital — Belmont, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Diego Pizzagalli, PhD — Mclean Hospital
• Study coordinator: Aliza Brown

Conditions Depression; Trauma, Psychological