NCT04923685 · University of Alabama at Birmingham
MicroRNA Correlates of Childhood Maltreatment and Suicidality
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Physically healthy
- Willing and able to provide informed consent 5\. 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
- Birmingham, Alabama
- Huntsville, Alabama
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations