MicroRNA Correlates of Childhood Maltreatment and Suicidality

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.

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Key information

Conditions

Major Depressive Disorder Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-60
Physically healthy
Willing and able to provide informed consent

Diagnosis of MDD or No history of mental illness

Exclusion criteria

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
Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month (NOTE that a positive UDS is not exclusionary except for hallucinogens, methamphetamine, or cocaine. People presenting intoxicated with alcohol may be included when a Breathalyzer test (Alco-Sensor IV) is negative as long as there is no history of recent dependence.
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.
Chemotherapy
Head injury with loss of consciousness in the past 6 months

Treatment and study plan

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.

Other names: TSST

Primary outcomes

MicroRNA response to stress

Time frame: 24 hours

MiRNAs methylation levels will be examined

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Stewart, BA

CONTACT

[email protected]

256-551-4428

Richard C Shelton, MD

CONTACT

[email protected]

256-551-6630

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Jun 11, 2021
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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