Actively Recruiting
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Led by University of Alabama at Birmingham · Updated on 2025-07-11
240
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adolescents and young adults aged 10 to 24 years to better understand depression and suicide by identifying biomarkers linked to these conditions. The study aims to improve medical and psychiatric care by examining how standard treatments for depression affect depressive and suicidal behaviors and related biomarkers, such as microRNAs. Participants diagnosed with major depressive disorder (MDD) will undergo genetic testing to identify biomarkers associated with suicidal thoughts and actions. The study involves an initial blood draw and assessments at the start, followed by a second blood draw and evaluations after six weeks of standard depression treatment. During the study, participants will be closely monitored through clinical assessments, including the Children's Depression Rating Scale-Revised and the Columbia Suicide Severity Rating Scale. Researchers will analyze clinical phenotypes at six weeks to assess treatment outcomes and biomarker changes. The total participation includes initial and follow-up visits over this six-week period to gather data on depression, suicidality, and biological markers.
CONDITIONS
Brief Title
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physically healthy
- Willing and able to provide informed consent (if under 18, parent or guardian consent is also required)
- Definite diagnosis of major depressive disorder (MDD) by DSM-5 criteria
- Children's Depression Rating Scale-Revised (CDRS-R) score of 30 or higher for MDD participants
- Columbia Suicide Severity Rating Scale (C-SSRS) score of 4 or higher over the last two weeks for suicidal ideation participants
- Suicide attempt within the previous two weeks requiring medical attention with at least medium intent on the Suicide Intent Scale
- No history of major mental illness or substance use disorder for non-psychiatric controls
You will not qualify if you...
- Pregnancy or lactation
- Post-partum state within 2 months of delivery or miscarriage
- Homicide risk as determined by clinical interview
- Lifetime history of psychotic disorder
- Alcohol or drug use disorder (except nicotine/caffeine) within the last month
- Use of hallucinogens (except cannabis) including phencyclidine in the last month
- Bipolar disorder
- Pervasive developmental disorder
- Cognitive disorder
- DSM-5 paranoid, schizoid, or schizotypal personality disorders
- Anorexia nervosa
- Recent myocardial infarction or unstable angina
- Active neoplasm in the past 6 months
- Immunosuppressive or corticosteroid therapy within the last month
- Chemotherapy in the last 6 months
- Head injury or loss of consciousness in the past 6 months
- Use of hallucinogens (except cannabis), methamphetamine, or cocaine in the last 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants undergo genetic testing to identify biomarkers related to suicidal ideation and treatment outcomes.
2 visits (blood draws and assessments at baseline and 6 weeks)
Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, United States, 35294
Actively Recruiting
Research Team
A
Allison Stewart, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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