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RecruitingNCT05437588Updated Jul 13, 2026

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

An interventional study of Genetic testing in Major Depressive Disorder, Suicidal Ideas and Suicide, Attempted, sponsored by University of Alabama at Birmingham. Recruiting at 2 sites in United States. Open to participants aged 10 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
10 Years to 24 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
  • Suicidal Ideas
  • Suicide, Attempted
  • MDD
  • Depression
  • Depression, Teen
  • Depression and Suicide
  • Depression in Adolescence
  • Suicide
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 240 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Browse University of Alabama at Birmingham studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

All participants:

  1. Physically healthy
  2. willing and able to provide (if under 18 also parent or guardian consent)

MDD participants:

  1. A definite diagnosis of
  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, or 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Other
    MDD Participant

    Participants with MDD will return at six weeks for a second blood draw and assessments

    Genetic: Genetic testing

Interventions

  • GeneticGenetic testing

    Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action

06

What researchers measure

Primary outcomes

  1. Clinical phenotype analysis

    Time frame: 6 Weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Jun 2027, 56 months after the start.

Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 56 months is above that.

Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Jun 29, 2022
StartActual
Oct 1, 2022
Primary completionEst.
Jun 29, 2027
CompletionEst.
Jun 30, 2027
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05437588
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Yogesh Dwivedi, PhD (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Jun 29, 2022
Start date
Oct 1, 2022
Primary completion
Jun 29, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Allison Stewart, MA
Contact
allisonstewart@uabmc.edu
256-551-4431

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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