Status:
RECRUITING
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Suicidal Ideas
Eligibility:
All Genders
10-24 years
Phase:
NA
Brief Summary
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This...
Eligibility Criteria
Inclusion
- All participants:
- Physically healthy
- willing and able to provide informed consent (if under 18 also parent or guardian consent)
- MDD participants:
- A definite diagnosis of DSM-5
- 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
- Exclusion criteria:
- Pregnancy or lactation
- post-partum state (being within 2 months of delivery or miscarriage);
- homicide risk as determined by clinical interview
- 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.
- 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
- use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05437588
Start Date
October 1 2022
End Date
June 30 2027
Last Update
July 11 2025
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, United States, 35294