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Selective Serotonin Reuptake Inhibitor

Sertraline for Depression (Re-EMBARC Trial)

Phase 4
Recruiting
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Re-EMBARC Trial Summary

This trial studies brain scans & EEGs to predict individual responses to Zoloft treatment for major depression.

Who is the study for?
This trial is for English-speaking adults with early-onset major depression, diagnosed per DSM-5 criteria. Participants must have had multiple depressive episodes or one lasting over two years and a significant level of current depression symptoms. They should be able to undergo MRI and EEG scans but not be at high suicide risk or have conditions like psychosis, bipolar disorder, substance abuse, unstable medical issues, contraindications to MRI, or certain treatments for depression.Check my eligibility
What is being tested?
The study aims to find brain biomarkers that predict how well individuals with major depression will respond to Sertraline (Zoloft), an SSRI antidepressant. Researchers will use fMRI and EEG to measure brain activity and connections before treatment begins.See study design
What are the potential side effects?
Sertraline may cause side effects such as nausea, sleepiness or insomnia, sexual dysfunction, tremors, increased sweating, dry mouth, diarrhea or constipation. It can also affect mood including risks of increased suicidal thoughts especially in young adults.

Re-EMBARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks
Secondary outcome measures
Change from Baseline on the Beck Anxiety Inventory (BAI) at 8 weeks
Change from Baseline on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 8 weeks
Change from Baseline on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR) at 8 weeks
+9 more

Side effects data

From 2002 Phase 4 trial • 110 Patients • NCT00000378
3%
orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertaline
Nortriptyline

Re-EMBARC Trial Design

1Treatment groups
Experimental Treatment
Group I: Sertraline hydrochloride, up to 200mg/day or maximum tolerable doseExperimental Treatment1 Intervention
Established FDA-approved treatment for major depressive disorder
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sertraline
2002
Completed Phase 4
~5470

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,194 Total Patients Enrolled
Lehigh UniversityOTHER
21 Previous Clinical Trials
4,260 Total Patients Enrolled

Media Library

Sertraline (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05892744 — Phase 4
Major Depressive Disorder Research Study Groups: Sertraline hydrochloride, up to 200mg/day or maximum tolerable dose
Major Depressive Disorder Clinical Trial 2023: Sertraline Highlights & Side Effects. Trial Name: NCT05892744 — Phase 4
Sertraline (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05892744 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit those who are 45 years of age and older to participate?

"The requirements for inclusion stipulate that the lower bound for participation is 18 and the upper limit rests at 65."

Answered by AI

What characteristics make someone an ideal candidate for this experiment?

"This clinical trial is in search of 50 patients who suffer from depression and are aged between 18 to 65. Qualified participants will be accepted for enrolment."

Answered by AI

To what degree could this procedure put patients at risk?

"There is ample evidence from clinical trials to suggest that this treatment has achieved a high degree of safety, earning it a score of 3."

Answered by AI

Is this research currently enrolling participants?

"Clinicaltrials.gov states that, while originally published on August 1st 2023 and last revised on May 26th 2023, this clinical trial is not actively recruiting patients presently. However, there are currently 1367 other studies in need of participants across the world."

Answered by AI

Who else is applying?

What site did they apply to?
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried many medications for depression over the past 40 years and experienced little to no improvement.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
Greg Fonzo 2023. "Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892744.
All > Depression Austin
~33 spots leftby Jun 2026
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