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
- Chronic Major Depression, Recurrent
- Major Depressive Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sertraline — DRUG50-200mg/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 doseEstablished 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
- Greg Fonzo, Ph.D.512-495-5856
- Lauren Enten, B.S.A
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600 | Austin | Texas | 78712 |
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