What is the mechanism of action of this treatment?

Vagal Nerve Stimulation (VNS) works by sending electrical impulses to the vagus nerve, which then transmits these signals to the brain, potentially altering neurotransmitter levels and improving mood regulation. This mechanism is crucial for depression patients, especially those with treatment-resistant depression, as it offers an alternative when traditional treatments fail. Other common treatments include antidepressants, which typically work by increasing levels of neurotransmitters like serotonin and norepinephrine, and psychotherapy, which helps patients develop coping strategies and change negative thought patterns. Understanding these mechanisms helps patients and doctors make informed decisions about the most appropriate and effective treatment options.

What side effects are associated with this type of intervention?

Vagal Nerve Stimulation (VNS) for depression is generally well-tolerated, with mild side effects such as voice changes, neck pain, and shortness of breath. In comparison, common treatments like SSRIs (e.g., fluoxetine, sertraline) often cause nausea, insomnia, and sexual dysfunction, while SNRIs (e.g., venlafaxine, duloxetine) can lead to increased blood pressure, dry mouth, and dizziness. Tricyclic antidepressants (e.g., amitriptyline) may cause weight gain, constipation, and blurred vision. Each treatment has a unique side effect profile, and the choice of therapy should be tailored to the patient's specific needs and medical history.

What prior FDA approvals exist?

The FDA has approved several treatments for depression, including pharmacological agents and neuromodulation devices. Vagal Nerve Stimulation (VNS) using devices like gammaCore™ is being explored for its efficacy in treating depression. Other neuromodulation treatments include Transcranial Magnetic Stimulation (TMS), which has been FDA-approved for patients with treatment-resistant depression. Additionally, various antidepressants such as SSRIs (e.g., escitalopram) and SNRIs (e.g., duloxetine) have been approved for managing depression. These treatments offer a range of options for patients who do not respond to first-line therapies.

What other types of research exist?

Promising alternatives to gammaCore™ for depression treatment include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in both acute and preventive treatment of migraines and may be useful for depression. 2) Deep Brain Stimulation (DBS), which has been effective in treatment-resistant cases of other psychiatric disorders and may offer benefits for severe depression. 3) Electroconvulsive Therapy (ECT), which is recommended for treatment-resistant schizophrenia and may also be effective for severe depression.

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Vagus Nerve Stimulation

Vagal Nerve Stimulation for Major Depressive Disorder

N/A

Waitlist Available

Led By Matthew Macaluso, M.D.

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-75 years old

Be older than 18 years old

Must not have

Being treated with benzodiazepines or other CNS depressants

No clinically significant neurological disease based on medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a small device that stimulates a nerve in the neck to help treat depression. It targets people with depression, especially those who haven't found relief with other treatments. The device works by sending gentle electrical signals to a nerve that can improve mood.

Who is the study for?

This trial is for adults aged 18-75 with Major Depressive Disorder (MDD), confirmed by specific diagnostic criteria, who speak English and have a significant level of depression. Excluded are those at immediate suicide risk, with certain neurological diseases or head injuries, recent mothers, pregnant or lactating women, patients with carotid artery narrowing or vagus nerve surgery history, substance abuse issues within the last three months, other primary psychiatric disorders besides MDD, and various autoimmune conditions.

What is being tested?

The study tests if gammaCore™—a non-invasive handheld device that stimulates the vagal nerve—can effectively treat major depression. It also aims to confirm the safety profile of this treatment method.

What are the potential side effects?

While not explicitly listed in your information provided, typical side effects from similar non-invasive vagal nerve stimulation devices may include headache, neck pain or discomfort where the device is used; tingling sensations; skin irritation; and muscle twitching.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that affects my nervous system, like benzodiazepines.

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I do not have any major neurological conditions.

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I am not pregnant or breastfeeding, and my pregnancy test was negative.

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I do not have any autoimmune diseases or a history of seizures.

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I have depression and my previous treatments haven't worked.

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I have had surgery to cut the vagus nerve in my neck.

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I have no open wounds or scars on my neck where I will be treated.

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I have been diagnosed with narrowed arteries in my neck.

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I have serious issues with high or low blood pressure or heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montgomery-Asberg Depression Rating Scale (MADRS) at 3 Months

Number of Participants With Adverse Events

Awards & Highlights

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: Intervention GroupExperimental Treatment1 Intervention

Treatment effects will be measured using standard rating scales including the HDRS-17, MADRS, SF-36, CSSR-S, CGI-I, CGI-S, which will be completed at each visit. The following scales will be completed at every other visit following the screening visit: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. At each study visit safety assessments including vital sign assessment and adverse event assessment will be completed. Subjects will also undergo physical examination and an ECG for safety during screening, after 8 weeks of treatment and at the end of 12 weeks of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

gammaCore™

2022

N/A

~10

0 / 10Eligibility criteria met

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

Vagal Nerve Stimulation (VNS) works by sending electrical impulses to the vagus nerve, which then transmits these signals to the brain, potentially altering neurotransmitter levels and improving mood regulation. This mechanism is crucial for depression patients, especially those with treatment-resistant depression, as it offers an alternative when traditional treatments fail. Other common treatments include antidepressants, which typically work by increasing levels of neurotransmitters like serotonin and norepinephrine, and psychotherapy, which helps patients develop coping strategies and change negative thought patterns. Understanding these mechanisms helps patients and doctors make informed decisions about the most appropriate and effective treatment options.

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