Major Depressive DisorderNCT05437588
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
A study testing Genetic testing in people with Major Depressive Disorder and Suicidal Ideas, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Suicidal Ideas, Suicide, Attempted
- What is being tested?
- Genetic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 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.
- 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
- use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Azka Aleezada, 205-996-2723, aaleezada@uabmc.edu
- Recruiting
UAB Huntsville Regional Medical Campus
Huntsville, Alabama, 35294
Jennifer Burns, MS, 256-551-4677, jenniferburns@uabmc.edu
Annalyse Alldredge, MA, 256-551-4431, hsvpsychresearch@uabmc.edu
About this study
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.
- Conditions
- Major Depressive Disorder, Suicidal Ideas, Suicide, Attempted, MDD, Depression, Depression, Teen
- Being tested
- Genetic testing
- Medical subject headings
- Depressive Disorder, Major, Suicide, Attempted, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testingGenetic
Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action
| Study group | Role | What they receive |
|---|---|---|
| MDD Participant | Other | Participants with MDD will return at six weeks for a second blood draw and assessments Receives: Genetic: Genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical phenotype analysis
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Oct 2022
- Primary completion29 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Yogesh Dwivedi, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437588
- Sponsor's protocol ID
- IRB-300009460
- Other IDs
- R01MH130539
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
- ClinicalTrials.gov ID
- NCT05437588
- Acronym / sponsor ID
- IRB-300009460
- Conditions
- Major Depressive Disorder, Suicidal Ideas, Suicide, Attempted, MDD, Depression, Depression, Teen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD Participant | Other | Genetic: Genetic testingParticipants with MDD will return at six weeks for a second blood draw and assessments |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Physically healthy
- willing and able to provide informed consent (if under 18 also parent or guardian consent)
- 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.
- 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.
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic testingAttempting to identify the genetic biomarker that can identify risk for suicidal ideation and action | Genetic | MDD Participant |
Primary outcome
Clinical phenotype analysis
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic testing in people with Major Depressive Disorder and Suicidal Ideas, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Stewart, MA (256-551-4431, allisonstewart@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical phenotype analysis (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.