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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Suicide, Attempted; Suicide; Major Depressive Disorder; Suicidal Ideas; MDD; Depression and Suicide; Depression in Adolescence; Depression, Teen
• Intervention / Treatment: Genetic: Genetic testing

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Stewart, MA; Phone Number: 256-551-4431; Email: allisonstewart@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Melissa Alexander; Email: lalexander@uabmc.edu
    • Huntsville, Alabama, United States, 35294
      • Recruiting
      • UAB Huntsville Regional Medical Campus
      • Contact: Brittany McCrory, BS; Phone Number: 256-551-4657; Email: bamccrory@uabmc.edu
      • Contact: Phone Number: 256-551-4431; Email: hsvpsychresearch@uabmc.edu
      • Principal Investigator: Yogesh Dwivedi, PhD
      • Principal Investigator: Richard C Shelton, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MDD Participant; Participants with MDD will return at six weeks for a second blood draw and assessments	Genetic: Genetic testing; Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical phenotype analysis	6 Weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Self-Injurious Behavior; Depression; Depressive Disorder; Suicide; Suicide, Attempted; Depressive Disorder, Major
• Other Study ID Numbers: IRB-300009460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No