MicroRNA Correlates of Childhood Maltreatment and Suicidality

NCT04923685 | Recruiting DMC

• 2 other identifiers: IRB-3000060245R01MH124248-02
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Major Depressive Disorder; Suicidal Ideation

Keywords

Depression; Suicidal Ideation; Suicidality; Healthy Control; Depression and Anxiety; Childhood Maltreatment

Outcome Measures

Primary Outcomes (1)

• MicroRNA response to stress

  MiRNAs methylation levels will be examined

  24 hours

Study Arms (6)

MDD with elevated CM and suicidality scores

Major Depressive Disorder with elevator childhood maltreatment and suicidality scores.

Other: Trier Social Stress Test

MDD with CM history but lower suicidality

Major Depressive disorder with childhood maltreatment history but lower suicidality scores.

Other: Trier Social Stress Test

MDD without CM but with elevated suicidality

Major Depressive Disorder without childhood maltreatment, but with elevated suicidality scores.

Other: Trier Social Stress Test

MDD without CM but with lower suicidality

Major Depressive Disorder without childhood maltreatment but with lower suicidality scores.

Other: Trier Social Stress Test

Healthy controls with CM history

Healthy controls with childhood maltreatment history,

Other: Trier Social Stress Test

Healthy controls without CM history

Healthy controls without childhood maltreatment history.

Other: Trier Social Stress Test

Interventions

Trier Social Stress Test OTHER

The TSST is a standardized test to induce acute psychological stress in humans. Participants will abstain from caffeine for 12 hours and nicotine for 2 hours prior to the test. An IV butterfly catheter will be placed in an arm vein and flushed with saline. Participants will rest for 15 minutes. A 10ml baseline blood sample will be drawn. They will perform the TSST task and then have 10ml of blood drawn at 0, 15, 30, 60, and 90 minutes post-TSST.

Also known as: TSST

Healthy controls with CM history; Healthy controls without CM history; MDD with CM history but lower suicidality; MDD with elevated CM and suicidality scores; MDD without CM but with elevated suicidality; MDD without CM but with lower suicidality

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People between the ages of 18 and 60 with either a history of Major Depressive Disorder or no lifetime history of any major mental illness.

You may qualify if:

• Age 18-60
• Physically healthy
• Willing and able to provide informed consent
• \. Diagnosis of MDD or No history of mental illness

You may not qualify if:

• Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy screen)
• Post-partum state (being within 2 months of delivery or miscarriage)
• Homicide risk as determined by clinical interview
• A lifetime history of psychotic disorder
• Any history of dissociation or dissociative disorder
• Bipolar disorder
• Pervasive developmental disorder
• Cognitive disorder
• Cluster A personality disorder
• Borderline personality disorder
• Anorexia nervosa
• Recent myocardial infarction
• Unstable angina
• Active neoplasm in the past 6 months
• Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine collection

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation; Depression; Anxiety Disorders

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Yogesh Dwivedi, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Stewart, BA

CONTACT

256-551-4428; allisonstewart@uabmc.edu

Richard C Shelton, MD

CONTACT

256-551-6630; rcshelton@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 11, 2021
• Study Start: February 26, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (2)