RecruitingNot Applicable

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

United States240 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range10 Years – 24 Years

SexALL

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Inclusion criteria

✓. 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.

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.

What they're measuring

Clinical phenotype analysis

Timeframe: 6 Weeks

Trial details

NCT IDNCT05437588

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-29

Contact for this trial

Allison Stewart, MA

256-551-4431 allisonstewart@uabmc.edu

View on ClinicalTrials.gov More Major Depressive Disorder trials