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

University of Alabama at Birmingham2 sites in 1 country240 target enrollmentOctober 1, 2022

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: University of Alabama at Birmingham
Enrollment: 240
Locations: 2
Primary Endpoint: Clinical phenotype analysis
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

June 30, 2027

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Yogesh Dwivedi, PhD

Professor

University of Alabama at Birmingham

Eligibility Criteria

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 \>=
•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:

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.