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New treatment option for Major Depressive Disorder
Official title Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
ClinicalTrials.gov ID: NCT05437588
What this study is testing
What is Genetic testing?
Genetic testing is an investigational medicine, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 24. Healthy volunteers may be eligible.
You may be able to join if
- 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 \>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS)...
You likely can't join if
- 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...
- recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last...
See the full eligibility 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 \>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \>=4 rated over the last two weeks. Suicide attempt group: 1\...
- 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...
- 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...
- use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 24 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.