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NCT05437588Recruiting

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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 research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
23 Jun 2022
Start date
1 Oct 2022
Primary completion date
29 Jun 2027
Lead sponsor
University of Alabama at Birmingham
Diseases
Depression
NCT number
NCT05437588

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 1 Oct 2022 to the primary completion date, 29 Jun 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 10 years to 24 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
UAB Huntsville Regional Medical Campus
Coordinator of this site? Confirm its status
HuntsvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.