Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT04923685

Conditions

Major Depressive Disorder

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Trier Social Stress Test

Study Details

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

Study ID

NCT04923685

Start date

Feb 26, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18-60
2. Physically healthy
3. Willing and able to provide informed consent

5\. Diagnosis of MDD or No history of mental illness

Exclusion Criteria:

1. Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy 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 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.
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 the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
17. Chemotherapy
18. Head injury with loss of consciousness in the past 6 months

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

MDD with elevated CM and suicidality scores

Major Depressive Disorder with elevator childhood maltreatment and suicidality scores.

MDD with CM history but lower suicidality

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

MDD without CM but with elevated suicidality

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

MDD without CM but with lower suicidality

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

Healthy controls with CM history

Healthy controls with childhood maltreatment history,

Healthy controls without CM history

Healthy controls without childhood maltreatment history.

Interventions

Trier Social Stress Test

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.

Primary outcome measure

  • MicroRNA response to stress [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Allison Stewart, BA

256-551-4428allisonstewart@uabmc.edu

Richard C Shelton, MD

256-551-6630rcshelton@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Azka Aleezada

205-996-2723aaleezada@uabmc.edu

UAB Huntsville Regional Medical Campus

Recruiting

Huntsville, Alabama, United States, 35294

Contacts

Annalyse M Alldredge, MA

256-551-4431aalldredge@uabmc.edu

Principal Investigator:

Yogesh Dwivedi, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.