Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT05892744

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Led by University of Texas at Austin · Updated on 2026-05-01

50

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

Sponsors

U

University of Texas at Austin

Lead Sponsor

L

Lehigh University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 DSM-5 (SCID-5)
  • Early onset of depression (before age 30) with either a current episode lasting more than 2 years or at least two lifetime major depressive episodes
  • Quick Inventory of Depression Symptomology Self-Report (QIDS) score greater than 14 at baseline and prior to first sertraline dose
  • Willing and able to undergo MRI and EEG procedures
Not Eligible

You will not qualify if you...

  • Non-early onset or non-chronic major depressive disorder
  • Failure to respond to prior adequate antidepressant treatment during current episode
  • Currently pregnant, planning pregnancy, or breastfeeding
  • History or current psychosis or bipolar disorder
  • Moderate or greater substance-use disorder in past 6 months
  • Unstable psychiatric or medical conditions requiring hospitalization or contraindicating study medication
  • Contraindications to MRI including unsafe implants or brain conditions
  • History of epilepsy, significant brain injury, brain surgery, or anticonvulsant use
  • Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation during current episode
  • Use of medications that interfere with study medication, including antipsychotics and mood stabilizers
  • Current regular depression-specific evidence-based psychotherapy
  • Considered a significant suicide risk by study investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600

Austin, Texas, United States, 78712

Actively Recruiting

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Research Team

G

Greg Fonzo, Ph.D.

CONTACT

L

Lauren Enten, B.S.A

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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