Identifying brain biomarkers to predict treatment response in depression
Official title: Establishing Multimodal Brain Biomarkers Using Data-driven Analytics for Treatment Selection in Depression
Run by University of Texas at Austin · NCT05892744 · Data updated 2026-11-12
This study is trying to find brain signals that can help predict how well people with major depression will respond to the antidepressant sertraline.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Status | Recruiting |
| Started | September 30, 2023 |
| Main results expected | July 15, 2027 |
| Study ends | July 15, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05892744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with major depressive disorder who have experienced early onset depression and meet specific criteria for chronic or recurrent episodes.
✕Probably not a fit
Patients who do not have early onset depression or whose current depressive episode has lasted less than two years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to identify brain biomarkers that can predict how individuals with major depression will respond to the antidepressant sertraline. Using advanced techniques like functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG), the researchers will analyze brain activity and connectivity patterns. The goal is to develop multimodal biomarkers that improve treatment selection for patients suffering from chronic and recurrent major depression. By leveraging data from a large publicly-available dataset and an independent cohort, the study seeks to enhance the precision of predicting treatment outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with major depression.
How similar studies have gone: Previous studies have shown promise in using neuroimaging biomarkers for predicting treatment response in depression, but this multimodal approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English as primary language, and comprehension suitable to understand experimenter instructions * Meet criteria for a current major depressive episode diagnosed through the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) (SCID-5) * Meet criteria for early onset (prior to age 30) of depression and either: a) current major depressive episode lasts for \> 2 years; or b) participant meets criteria for recurrent major depression as evidenced by 2 or more major depressive episodes (including current episode) in their lifetime. These criteria will be assessed by the SCID-5. * Have a Quick Inventory of Depression Symptomology Self-Report Measures (QIDS) score \> 14 at baseline and the week prior to first Sertraline administration * Willing and able to undergo MRI and EEG procedures. Exclusion Criteria: * Non-early onset (i.e., after age 30), non-chronic (current episode lasting less than 2 years or only one lifetime major depressive episode, including current episode) qualifying Major Depressive Disorder * Must not have failed to respond to any prior antidepressant treatment in the current episode of sufficient duration and dose as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire * Currently pregnant, planning to become pregnant, or breastfeeding * Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview * Meeting DSM-5 criteria for a substance-use disorder of moderate or greater severity in the past 6 months * Unstable psychiatric or medical conditions that may require hospitalizations or contraindicate study medication (i.e. autism spectrum disorder, schizophrenia, cancer, congestive heart failure, etc.) * Contraindications to MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and/or cause large distortions in imaging data, etc. * History of epilepsy, moderate or severe traumatic brain injury, penetrating head injury, brain surgery, brain tumors, or any condition requiring an anticonvulsant * Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation during the current depressive episode * Concomitant medication use that are likely to interfere or obscure effects from the study medication, including but not limited to antipsychotics and mood stabilizers * Current regular depression-specific evidence-based psychotherapy treatment * Considered by the investigative team to be a significant suicide risk as evidence by self-report or clinical interview
Where it's running
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Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
Austin, Texas, United States Recruiting
Study contacts
- Study coordinator: Greg Fonzo, Ph.D.
- Email: fonzolab@austin.utexas.edu
- Phone: 512-495-5856
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.