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

NCT05437588 | Recruiting

• 2 other identifiers: IRB-300009460R01MH130539
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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 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

Major Depressive Disorder; Suicidal Ideas; Suicide, Attempted; MDD; Depression; Depression, Teen; Depression and Suicide; Depression in Adolescence; Suicide

Outcome Measures

Primary Outcomes (1)

• Clinical phenotype analysis

  6 Weeks

Study Arms (1)

MDD Participant

OTHER

Participants with MDD will return at six weeks for a second blood draw and assessments

Genetic: Genetic testing

Interventions

Genetic testing GENETIC

Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action

MDD Participant

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• \. 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:
• \. No history of any major mental illness (excluding specific phobia) or substance use disorder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Suicide, Attempted; Depression; Suicide

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Allison Stewart, MA

CONTACT

256-551-4431; allisonstewart@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (2)