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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial aims to use brain scans to predict how well patients with major depression will respond to the antidepressant sertraline. Sertraline, one of the oldest antidepressants, remains the most effective treatment for depression. By identifying specific brain activity patterns, doctors hope to better tailor treatments for each patient, improving outcomes for those who may not respond to typical treatments.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks
Secondary study objectives
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 moreSide effects data
From 2002 Phase 4 trial • 110 Patients • NCT000003783%
orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertaline
Nortriptyline
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Selective Serotonin Reuptake Inhibitors (SSRIs), such as Sertraline, work by increasing the levels of serotonin in the brain. They achieve this by inhibiting the reuptake of serotonin into the presynaptic cell, making more serotonin available to bind to the postsynaptic receptor.
This increase in serotonin levels helps improve mood and reduce symptoms of depression. Psychotherapy, particularly Cognitive Behavioral Therapy (CBT), works by helping patients identify and change negative thought patterns and behaviors that contribute to their depression.
These treatments are crucial for MDD patients as they address both the biological and psychological aspects of the disorder, providing a comprehensive approach to managing and alleviating symptoms.
Bulimia nervosa : a review of therapy research.
Bulimia nervosa : a review of therapy research.
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
374 Previous Clinical Trials
86,125 Total Patients Enrolled
Lehigh UniversityOTHER
22 Previous Clinical Trials
4,670 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an antidepressant fail to work for me in this current episode, according to the MGH standards.I have a history of serious brain conditions or injuries.I am currently receiving therapy for depression.I do not have any mental or physical health conditions that could worsen with study medication.I have received treatments like ECT, VNS, or TMS for my current depression.I am not taking medications like antipsychotics or mood stabilizers that could affect the study.My depression started after I turned 30 and hasn't been constant over the years.My depression score is above 14 before starting Sertraline.I was diagnosed with depression before 30 and have had long or repeated major episodes.I cannot have an MRI due to certain medical conditions or implants.
Research Study Groups:
This trial has the following groups:- Group 1: Sertraline hydrochloride, up to 200mg/day or maximum tolerable dose
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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