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NCT05892744RecruitingPhase 4

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Establishing Multimodal Brain Biomarkers Using Data-driven Analytics for Treatment Selection in Depression

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

The purpose of the study is to identify brain biomarkers and characteristics that predict individual responses to treatment of major depression with the antidepressant drug sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI) antidepressant. Our central hypothesis is that brain activity and connections jointly measured with functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) will be able to predict an individual's response to sertraline treatment.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
26 May 2023
Start date
30 Sept 2023
Primary completion date
15 Jul 2027
Lead sponsor
University of Texas at Austin
Diseases
Depression
NCT number
NCT05892744

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From 30 Sept 2023 to the primary completion date, 15 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview
  • 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

Other illness

  • 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

Age

  • 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

Other

  • Currently pregnant, planning to become pregnant, or breastfeeding
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.