Recruiting

Brain Biomarkers

Sponsor:

University of Texas at Austin

Code:

NCT05892744

Conditions

Major Depressive Disorder

Chronic Major Depression, Recurrent

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Sertraline

Study Details

Brief summary:

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

Major Depressive Disorder

Chronic Major Depression, Recurrent

Study ID

NCT05892744

Start date

Sep 30, 2023

Status verified date

Apr, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Sertraline hydrochloride, up to 200mg/day or maximum tolerable dose

Established FDA-approved treatment for major depressive disorder

Interventions

Sertraline

50-200mg/day

Primary outcome measure

  • Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Greg Fonzo, Ph.D.

512-495-5856fonzolab@austin.utexas.edu

Lauren Enten, B.S.A

lauren.enten@austin.utexas.edu

Locations

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

Recruiting

Austin, Texas, United States, 78712

Contacts

Lauren Enten, B.S.A.

512-495-5856lauren.enten@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Depression
  • Chronic Depression
  • Major Depression
  • Recurrent Depression
  • antidepressant
  • sertraline
  • fMRI
  • EEG
  • biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-05-01.