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Recruiting

NCT Number: NCT05437588

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.

Recruiting

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Key information

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

Genetic Testing

Genetic

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

Primary outcomes

  1. Clinical phenotype analysis

    Time frame: 6 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Stewart, MA

CONTACT

[email protected]

256-551-4431

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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