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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 24 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for signs in the blood, such as miRNA, that may be linked to depression and suicide risk in teens. It also studies how standard depression treatment changes these signs, depression symptoms, and suicidal thoughts and actions. It includes teens with depression or recent suicide attempts, and a comparison group without major mental illness.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants must be physically healthy.
  • All must be willing and able to agree to join. Those under 18 also need a parent or guardian’s consent.
  • Depression group: Must have a confirmed diagnosis of major depressive disorder and score at least 30 on the CDRS-R depression rating scale.
  • Suicidal thoughts group: Must score at least 4 on the C-SSRS suicide risk scale for the past 2 weeks.
  • Suicide attempt group: Must have attempted suicide in the past 2 weeks, needed medical care, and had at least a medium intent to die on the Suicide Intent Scale.
  • Comparison group: Must have no history of major mental illness or a substance use disorder. A specific phobia, or strong fear of a certain thing, is allowed.

Who can't join

  • Pregnant, breastfeeding, or within 2 months of giving birth or having a miscarriage.
  • Found during an interview to be at risk of killing another person.
  • Any history of a psychotic disorder, which can cause trouble knowing what is real; or bipolar disorder, which causes major mood shifts.
  • A developmental disorder, a disorder affecting thinking or memory, or anorexia nervosa, an eating disorder.
  • Paranoid, schizoid, or schizotypal personality disorder. Other personality disorders are allowed if the person meets the depression requirements.
  • An alcohol or drug use disorder in the past month, except nicotine or caffeine; hallucinogen use in the past month, except cannabis; or methamphetamine or cocaine use in the past 2 weeks.
  • A recent heart attack, unstable angina (heart-related chest pain), active cancer in the past 6 months, or chemotherapy.
  • Medicines that weaken the immune system or corticosteroids in the past month; or a head injury or loss of consciousness in the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

AL