Major Depressive DisorderNCT04923685
MicroRNA Correlates of Childhood Maltreatment and Suicidality
An observational study of Major Depressive Disorder and Suicidal Ideation, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Suicidal Ideation
- What is being tested?
- Trier Social Stress Test
- Type of treatment
- Injection or infusion
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2021to Dec 2027
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People between the ages of 18 and 60 with either a history of Major Depressive Disorder or no lifetime history of any major mental illness.
Who may be able to join
- Age 18-60
- Physically healthy
- Willing and able to provide informed consent
- 5. Diagnosis of MDD or No history of mental illness
Who cannot join
- Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy screen)
- Post-partum state (being within 2 months of delivery or miscarriage)
- Homicide risk as determined by clinical interview
- A lifetime history of psychotic disorder
- Any history of dissociation or dissociative disorder
- Bipolar disorder
Show all 18Show fewer
- Pervasive developmental disorder
- Cognitive disorder
- Cluster A personality disorder
- Borderline personality disorder
- Anorexia nervosa
- Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month (NOTE that a positive UDS is not exclusionary except for hallucinogens, methamphetamine, or cocaine. People presenting intoxicated with alcohol may be included when a Breathalyzer test (Alco-Sensor IV) is negative as long as there is no history of recent dependence.
- Recent myocardial infarction
- Unstable angina
- Active neoplasm in the past 6 months
- Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
- Chemotherapy
- Head injury with loss of consciousness in the past 6 months
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
Annalyse M Alldredge, MA, 256-551-4431, aalldredge@uabmc.edu
Yogesh Dwivedi, PhD
About this study
This is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.
Read the detailed description
The purpose of the study is to determine if the relationship between a history of childhood maltreatment (CM) and suicide risk is associated with alterations in the expression and epigenetic modification of specific microRNAs (miRNAs), thereby providing a molecular signature of suicide risk in people with CM. miRNAs are short regulatory RNAs that transduce environmental events into changes in protein synthesis in cells. The environment can induce permanent changes in miRNA expression. Aim 1 is to identify a set of neural-derived exosomal miRNAs that are associated with the interaction of suicidality and CM. Aim 2 is to examine whether an acute experimental stressor, the Trier Social Stress Test (TSST), impacts the expression of these miRNAs in suicidal patients with and without CM. Aim 3 will examine potential mechanisms by which altered miRNAs may contribute to CM-associated suicidal behavior. Aim 4 will examine if changes in CM-associated miRNAs are explained by modifications in their DNA methylation.
- Conditions
- Major Depressive Disorder, Suicidal Ideation
- Being tested
- Trier Social Stress Test
- Keywords
- Depression, Suicidal Ideation, Suicidality, Healthy Control, Depression and Anxiety, Childhood Maltreatment
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TestOther
Also called TSST
The TSST is a standardized test to induce acute psychological stress in humans. Participants will abstain from caffeine for 12 hours and nicotine for 2 hours prior to the test. An IV butterfly catheter will be placed in an arm vein and flushed with saline. Participants will rest for 15 minutes. A 10ml baseline blood sample will be drawn. They will perform the TSST task and then have 10ml of blood drawn at 0, 15, 30, 60, and 90 minutes post-TSST.
| Study group | Role | What they receive |
|---|---|---|
| MDD with elevated CM and suicidality scores | Major Depressive Disorder with elevator childhood maltreatment and suicidality scores. Receives: Other: Trier Social Stress Test | |
| MDD with CM history but lower suicidality | Major Depressive disorder with childhood maltreatment history but lower suicidality scores. Receives: Other: Trier Social Stress Test | |
| MDD without CM but with elevated suicidality | Major Depressive Disorder without childhood maltreatment, but with elevated suicidality scores. Receives: Other: Trier Social Stress Test | |
| MDD without CM but with lower suicidality | Major Depressive Disorder without childhood maltreatment but with lower suicidality scores. Receives: Other: Trier Social Stress Test | |
| Healthy controls with CM history | Healthy controls with childhood maltreatment history, Receives: Other: Trier Social Stress Test | |
| Healthy controls without CM history | Healthy controls without childhood maltreatment history. Receives: Other: Trier Social Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA response to stress
MiRNAs methylation levels will be examined
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start26 Feb 2021
- Primary completion31 Mar 2027 (estimated)
- Study completionDec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 450 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
- Investigators
- Yogesh Dwivedi, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923685
- Sponsor's protocol ID
- IRB-300006024
- Other IDs
- 5R01MH124248-02
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Correlates of Childhood Maltreatment and Suicidality
- ClinicalTrials.gov ID
- NCT04923685
- Acronym / sponsor ID
- IRB-300006024
- Conditions
- Major Depressive Disorder, Suicidal Ideation
- Keywords
- Depression, Suicidal Ideation, Suicidality, Healthy Control, Depression and Anxiety, Childhood Maltreatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2021 (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 is a research study to find out if childhood trauma and stress are associated with depression or suicidal risk. The study will assess the effects of both short-term and long-term stress on biomarker (e.g. miRNA [MiRNA]) levels. miRNAs are a type of RNA (genetic material that is translated into protein) that are found in throughout the body and blood. They are called microRNA because their size is much smaller than typical RNA molecules. miRNAs are highly responsive to environment. This responsiveness is reflected in their expression in individuals who are affected by environment such as stress. The investigators are gathering genetic material, including DNA and RNA, from each participant. The RNA will be taken from the small vesicles and cells in the participant's blood and analyzed. The vesicles are small objects that occur normally in the blood and that contain RNA. This information may help us to understand the cause of mental illness and to improve medical and psychiatric care in the future. There will be 450 participants enrolled in this study.
Detailed description
The purpose of the study is to determine if the relationship between a history of childhood maltreatment (CM) and suicide risk is associated with alterations in the expression and epigenetic modification of specific microRNAs (miRNAs), thereby providing a molecular signature of suicide risk in people with CM. miRNAs are short regulatory RNAs that transduce environmental events into changes in protein synthesis in cells. The environment can induce permanent changes in miRNA expression. Aim 1 is to identify a set of neural-derived exosomal miRNAs that are associated with the interaction of suicidality and CM. Aim 2 is to examine whether an acute experimental stressor, the Trier Social Stress Test (TSST), impacts the expression of these miRNAs in suicidal patients with and without CM. Aim 3 will examine potential mechanisms by which altered miRNAs may contribute to CM-associated suicidal behavior. Aim 4 will examine if changes in CM-associated miRNAs are explained by modifications in their DNA methylation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MDD with elevated CM and suicidality scores | – | Other: Trier Social Stress TestMajor Depressive Disorder with elevator childhood maltreatment and suicidality scores. |
| MDD with CM history but lower suicidality | – | Other: Trier Social Stress TestMajor Depressive disorder with childhood maltreatment history but lower suicidality scores. |
| MDD without CM but with elevated suicidality | – | Other: Trier Social Stress TestMajor Depressive Disorder without childhood maltreatment, but with elevated suicidality scores. |
| MDD without CM but with lower suicidality | – | Other: Trier Social Stress TestMajor Depressive Disorder without childhood maltreatment but with lower suicidality scores. |
| Healthy controls with CM history | – | Other: Trier Social Stress TestHealthy controls with childhood maltreatment history, |
| Healthy controls without CM history | – | Other: Trier Social Stress TestHealthy controls without childhood maltreatment history. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People between the ages of 18 and 60 with either a history of Major Depressive Disorder or no lifetime history of any major mental illness.
Key inclusion criteria (4 listed)
- Age 18-60
- Physically healthy
- Willing and able to provide informed consent
- 5. Diagnosis of MDD or No history of mental illness
Key exclusion criteria (18 listed)
- Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy screen)
- Post-partum state (being within 2 months of delivery or miscarriage)
- Homicide risk as determined by clinical interview
- A lifetime history of psychotic disorder
- Any history of dissociation or dissociative disorder
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 |
|---|---|---|
| Trier Social Stress TestAlso: TSSTThe TSST is a standardized test to induce acute psychological stress in humans. Participants will abstain from caffeine for 12 hours and nicotine for 2 hours prior to the test. An IV butterfly catheter will be placed in an arm vein and flushed with saline. Participants will rest for 15 minutes. A 10ml baseline blood sample will be drawn. They will perform the TSST task and then have 10ml of blood drawn at 0, 15, 30, 60, and 90 minutes post-TSST. | Other | Healthy controls with CM history, Healthy controls without CM history, MDD with CM history but lower suicidality, MDD with elevated CM and suicidality scores, MDD without CM but with elevated suicidality, MDD without CM but with lower suicidality |
Primary outcome
MicroRNA response to stress
Time frame: 24 hours
MiRNAs methylation levels will be examined
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 30 Mar 2026.
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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.
Yogesh Dwivedi, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Suicidal Ideation, 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 4 inclusion and 18 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 30 Mar 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, BA (256-551-4428, allisonstewart@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MicroRNA response to stress (time frame: 24 hours). 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 30 Mar 2026.