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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-24
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Physically healthy

willing and able to provide informed consent (if under 18 also parent or guardian consent)

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Genetic testing

    Genetic

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

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: MDD ParticipantOther 1 intervention

Trial outcomes

Primary outcomes

1

Clinical phenotype analysis

Time frame
6 Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator