MicroRNA Correlates of Childhood Maltreatment and Suicidality

Last updated: May 12, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

Trier Social Stress Test

Clinical Study ID

NCT04923685
IRB-300006024
5R01MH124248-02
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-60

  2. Physically healthy

  3. Willing and able to provide informed consent

  4. Diagnosis of MDD or No history of mental illness

Exclusion

Exclusion Criteria:

  1. Pregnancy or lactation (women of reproductive potential must have a negative urinepregnancy screen)

  2. Post-partum state (being within 2 months of delivery or miscarriage)

  3. Homicide risk as determined by clinical interview

  4. A lifetime history of psychotic disorder

  5. Any history of dissociation or dissociative disorder

  6. Bipolar disorder

  7. Pervasive developmental disorder

  8. Cognitive disorder

  9. Cluster A personality disorder

  10. Borderline personality disorder

  11. Anorexia nervosa

  12. Alcohol or drug dependence (except nicotine and caffeine) within the last month orthe use of any hallucinogen (except cannabis), including phencyclidine in the lastmonth (NOTE that a positive UDS is not exclusionary except for hallucinogens,methamphetamine, or cocaine. People presenting intoxicated with alcohol may beincluded when a Breathalyzer test (Alco-Sensor IV) is negative as long as there isno history of recent dependence.

  13. Recent myocardial infarction

  14. Unstable angina

  15. Active neoplasm in the past 6 months

  16. Immunosuppressive or corticosteroid therapy within the last month, with thefollowing exceptions: any inhaled, intranasal, topical or vaginal corticosteroidsare allowed.

  17. Chemotherapy

  18. Head injury with loss of consciousness in the past 6 months

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Trier Social Stress Test
Phase:
Study Start date:
February 26, 2021
Estimated Completion Date:
September 30, 2025

Study Description

The purpose of the study is to determine if the relationship between a history of childhood maltreatment (CM) and suicide risk is associated with alterations in the expression and epigenetic modification of specific microRNAs (miRNAs), thereby providing a molecular signature of suicide risk in people with CM. miRNAs are short regulatory RNAs that transduce environmental events into changes in protein synthesis in cells. The environment can induce permanent changes in miRNA expression. Aim 1 is to identify a set of neural-derived exosomal miRNAs that are associated with the interaction of suicidality and CM. Aim 2 is to examine whether an acute experimental stressor, the Trier Social Stress Test (TSST), impacts the expression of these miRNAs in suicidal patients with and without CM. Aim 3 will examine potential mechanisms by which altered miRNAs may contribute to CM-associated suicidal behavior. Aim 4 will examine if changes in CM-associated miRNAs are explained by modifications in their DNA methylation.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UAB Huntsville Regional Medical Campus

    Huntsville, Alabama 35294
    United States

    Active - Recruiting

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