NCT05437588 Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
| NCT ID | NCT05437588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-06-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2022-10-01 with a primary completion date of 2027-06-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05437588 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 24 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05437588 currently recruiting?
Yes, NCT05437588 is actively recruiting participants. Contact the research team at allisonstewart@uabmc.edu for enrollment information.
Where is the NCT05437588 trial being conducted?
This trial is being conducted at Birmingham, United States, Huntsville, United States.
Who is sponsoring the NCT05437588 clinical trial?
NCT05437588 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 240 participants.