Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

NCT05892744 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00003901
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks

  Standardized clinician-administered measure of depression symptom severity. Scores range from 0-52. Lower scores indicate less depressive symptomatology, and so are the more desirable.

  8 weeks

Secondary Outcomes (12)

• Change from Baseline on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR) at 8 weeks

  8 weeks

• Change from Baseline on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 8 weeks

  8 weeks

• Change from Baseline on the Beck Anxiety Inventory (BAI) at 8 weeks

  8 weeks

• Change from Baseline on the Spielberger State Trait Anxiety Inventory-Trait Form (STAI-T) at 8 weeks

  8 weeks

• Change from baseline on the Anger Attacks Questionnaire (AAQ) at 8 weeks

  8 weeks

Study Arms (1)

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

OTHER

Established FDA-approved treatment for major depressive disorder

Drug: Sertraline

Interventions

Sertraline DRUG

50-200mg/day

Also known as: Zoloft

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Lehigh University: collaborator

Study Sites (1)

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

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Greg Fonzo, Ph.D.

CONTACT

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

Lauren Enten, B.S.A

CONTACT

lauren.enten@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open-label, single-arm treatment

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)