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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jun 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how certain markers in the blood, called microRNAs, can help us understand depression and suicidal thoughts in teenagers. The goal is to identify these markers to improve how we treat these serious conditions in the future. The study will also examine how standard depression treatments can affect both symptoms of depression and these blood markers.

To participate in this trial, individuals must be physically healthy and willing to provide consent (if under 18, a parent or guardian must also consent). They should have a diagnosis of major depressive disorder or have experienced suicidal thoughts or attempts recently. Participants will not be eligible if they are pregnant, have certain serious health conditions, or a history of specific mental health disorders. Those who join the study can expect to contribute to important research that may lead to better support and treatments for young people facing depression and suicidal thoughts.

Gender

ALL

Eligibility criteria

• 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.