MicroRNA Correlates of Childhood Maltreatment and Suicidality
Recruiting · NCT04923685 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- UAB Huntsville Regional Medical Campus - Huntsville, Alabama, United States