Actively Recruiting

Phase Not Applicable
Age: 10Years - 24Years
All Genders
Healthy Volunteers
NCT05437588

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

247 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years - 24Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be physically healthy
  • Willing and able to provide informed consent (if under 18, parent or guardian consent is required)
  • For MDD group: definite diagnosis according to DSM-5
  • For MDD group: Children's Depression Rating Scale-Revised (CDRS-R) score of 30 or higher
  • For suicidal ideation group: Columbia Suicide Severity Rating Scale (C-SSRS) score of 4 or higher in the last two weeks
  • For suicide attempt group: suicide attempt in the previous two weeks requiring medical attention and showing at least medium intent on the Suicide Intent Scale
  • For non-psychiatric controls: no history of major mental illness (excluding specific phobia) or substance use disorder
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Post-partum state within 2 months of delivery or miscarriage
  • Risk of homicide as assessed 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 (other personality disorders allowed if MDD criteria met)
  • Anorexia nervosa
  • Recent myocardial infarction or unstable angina
  • Active cancer in past 6 months
  • Immunosuppressive or corticosteroid therapy in last month
  • Chemotherapy in last 6 months
  • Head injury or loss of consciousness in last 6 months
  • Use of hallucinogens (except cannabis), methamphetamine, or cocaine in last 2 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Allison Stewart, MA

CONTACT

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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