What side effects are associated with this type of intervention?

Selective Serotonin Reuptake Inhibitors (SSRIs), including sertraline, are commonly used to treat Major Depressive Disorder and are generally well-tolerated. However, they can cause several dose-related side effects such as jitteriness, restlessness, anxiety, agitation, headache, sexual dysfunction, gastrointestinal symptoms (diarrhea and nausea), and insomnia. Headache and jitteriness often subside after the first four to seven days of treatment. It is important to monitor these side effects, especially in debilitated patients, and adjust the treatment as necessary.

What prior FDA approvals exist?

Selective serotonin reuptake inhibitors (SSRIs) have been widely approved by the FDA for the treatment of Major Depressive Disorder (MDD). Notable SSRIs include fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), and escitalopram (Lexapro). These medications are favored due to their efficacy and tolerability. Studies have shown that SSRIs like sertraline and escitalopram provide a good balance of efficacy and acceptability, making them common choices for initial treatment of MDD.

What other types of research exist?

Promising novel alternatives to Sertraline for Major Depressive Disorder patients include: 1) Venlafaxine (an SNRI) which has shown similar efficacy to SSRIs with potentially fewer side effects, 2) Cognitive Behavioral Therapy (CBT) combined with pharmacotherapy, which has demonstrated improved outcomes in treatment-resistant depression, and 3) MDMA-assisted psychotherapy, which has shown large effects in treatment-resistant PTSD and may be applicable to MDD. Additionally, newer generation antidepressants and augmentation strategies such as combining SSRIs with atypical antipsychotics or other agents like buspirone or thyroid hormone are also considered promising.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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 more

Side effects data

From 2002 Phase 4 trial • 110 Patients • NCT00000378

orthostatic hypotension

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.