Identifying biomarkers for depression and suicide in adolescents
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
This study is trying to find specific markers in the body that can help understand depression and suicidal thoughts in teenagers, while also looking at how standard treatments affect these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 10 Years to 24 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT05437588 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers related to major depressive disorder and suicidality in adolescents. It will assess the effects of standard depression treatments on both depressive and suicidal behaviors, as well as on specific biomarkers such as microRNAs. Participants will include those diagnosed with major depressive disorder, those experiencing suicidal ideation, and individuals who have recently attempted suicide, alongside non-psychiatric controls. The research seeks to enhance understanding of the links between these conditions to improve future medical and psychiatric care.
Who should consider this trial
Good fit: Ideal candidates include adolescents diagnosed with major depressive disorder, those with suicidal ideation, or individuals who have recently attempted suicide.
Not a fit: Patients with no history of major mental illness or substance use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for adolescents suffering from depression and suicidal thoughts.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for mental health conditions, but this specific approach focusing on neural-derived plasma exosomal microRNAs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All participants: 1. Physically healthy 2. willing and able to provide informed consent (if under 18 also parent or guardian consent) MDD participants: 1. A definite diagnosis of DSM-5 2. a Children's Depression Rating Scale-Revised (CDRS-R) score \>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \>=4 rated over the last two weeks. Suicide attempt group: 1\. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale. Non-psychiatric controls: 1\. No history of any major mental illness (excluding specific phobia) or substance use disorder. Exclusion Criteria: * Exclusion criteria: 1. Pregnancy or lactation 2. post-partum state (being within 2 months of delivery or miscarriage); 3. homicide risk as determined by clinical interview 4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa. 5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months 6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- UAB Huntsville Regional Medical Campus — Huntsville, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Allison Stewart, MA
- Email: allisonstewart@uabmc.edu
- Phone: 256-551-4431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.