MicroRNA Correlates of Childhood Maltreatment and Suicidality

Conditions

• Major Depressive Disorder
• Suicidal Ideation

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

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.

Study Details

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.

Key Dates

Start date

Feb 26, 2021

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

450 participants (estimated)

Arms

• Arm: MDD with elevated CM and suicidality scores
  Major Depressive Disorder with elevator childhood maltreatment and suicidality scores.
• Arm: MDD with CM history but lower suicidality
  Major Depressive disorder with childhood maltreatment history but lower suicidality scores.
• Arm: MDD without CM but with elevated suicidality
  Major Depressive Disorder without childhood maltreatment, but with elevated suicidality scores.
• Arm: MDD without CM but with lower suicidality
  Major Depressive Disorder without childhood maltreatment but with lower suicidality scores.
• Arm: Healthy controls with CM history
  Healthy controls with childhood maltreatment history,
• Arm: Healthy controls without CM history
  Healthy controls without childhood maltreatment history.

Primary Outcome Measure

MicroRNA response to stress [ Time Frame: 24 hours ]

Central Contacts

• Allison Stewart, BA
  256-551-4428
  [email protected]
• Richard C Shelton, MD
  256-551-6630
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

Related Studies

• Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
  Recruiting · Auburn University · Auburn, Alabama
• Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
  PHASE3 · Recruiting · Intra-Cellular Therapies, Inc. · Huntsville, Alabama
• Using TMS to Understand Neural Processes of Social Motivation
  Recruiting · Auburn University · Auburn, Alabama