RECRUITING

MicroRNA Correlates of Childhood Maltreatment and Suicidality

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MicroRNA Correlates of Childhood Maltreatment and Suicidality

Quick Facts

Study Start:2021-02-26
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04923685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-60
  2. 2. Physically healthy
  3. 3. Willing and able to provide informed consent
  4. 5. Diagnosis of MDD or No history of mental illness
  1. 1. Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy screen)
  2. 2. Post-partum state (being within 2 months of delivery or miscarriage)
  3. 3. Homicide risk as determined by clinical interview
  4. 4. A lifetime history of psychotic disorder
  5. 5. Any history of dissociation or dissociative disorder
  6. 6. Bipolar disorder
  7. 7. Pervasive developmental disorder
  8. 8. Cognitive disorder
  9. 9. Cluster A personality disorder
  10. 10. Borderline personality disorder
  11. 11. Anorexia nervosa
  12. 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. 13. Recent myocardial infarction
  14. 14. Unstable angina
  15. 15. Active neoplasm in the past 6 months
  16. 16. Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
  17. 17. Chemotherapy
  18. 18. Head injury with loss of consciousness in the past 6 months

Contacts and Locations

Study Contact

Allison Stewart, BA
CONTACT
256-551-4428
allisonstewart@uabmc.edu
Richard C Shelton, MD
CONTACT
256-551-6630
rcshelton@uabmc.edu

Principal Investigator

Yogesh Dwivedi, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Yogesh Dwivedi, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-26
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-02-26
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Suicidal Ideation