Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT05892744
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sertraline — DRUG
    50-200mg/day

Study Details

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 Dates

Start date
Sep 30, 2023
Status verified
Apr 2026
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Sertraline hydrochloride, up to 200mg/day or maximum tolerable dose
    Established FDA-approved treatment for major depressive disorder

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

Locations (1)

FacilityCityStateZIPSite coordinators
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600AustinTexas78712
Lauren Enten, B.S.A.
512-495-5856

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