Recruiting

Biomarkers for Depression

Sponsor:

University of Alabama at Birmingham

Code:

NCT05437588

Conditions

Major Depressive Disorder

Suicidal Ideas

Suicide, Attempted

MDD

Depression

Eligibility Criteria

Sex: All

Age: 10 - 24

Healthy Volunteers: Accepted

Interventions

Genetic testing

Study Details

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.

Conditions

Major Depressive Disorder

Suicidal Ideas

Suicide, Attempted

MDD

Depression

Study ID

NCT05437588

Start date

Oct 1, 2022

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 24

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: MDD Participant

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

Interventions

Genetic testing

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

Primary outcome measure

  • Clinical phenotype analysis [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

UAB Huntsville Regional Medical Campus

Recruiting

Huntsville, Alabama, United States, 35294

Contacts

Principal Investigator:

Yogesh Dwivedi, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-13.