Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Recruiting now · Phase 4

Conditions studied: Major Depressive Disorder, Chronic Major Depression, Recurrent

In brief

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.

Key facts

Study ID: NCT05892744
Run by: University of Texas at Austin
People needed: 50
Starts: 2023-09-30
Expected to finish: 2027-07-15
Last updated by the study team: 2026-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600 — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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