What side effects are associated with this type of intervention?

Common side effects of neuromodulation treatments for depression, such as transcranial magnetic stimulation (TMS) and similar neurostimulation techniques, include mild device-associated adverse events like a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain (e.g., arm, shoulder, or neck pain). Serious adverse events are rare. These treatments are generally well-tolerated, but patients with epilepsy should avoid TMS due to the theoretical risk of triggering seizures.

What prior FDA approvals exist?

The FDA has approved several neurostimulation treatments for depression, including transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS). TMS involves stimulating the brain using magnetic fields and is typically used when other treatments have failed. VNS involves electrical stimulation of the vagus nerve and is also used for treatment-resistant depression. While specific FDA approvals for combined occipital and trigeminal neurostimulation (eCOT-NS) like the Relivion®DP device are not mentioned, these approvals highlight the FDA's recognition of neurostimulation as a viable treatment option for depression.

What other types of research exist?

Promising alternatives to Relivion®DP for depression treatment include Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in both acute and preventive treatment of migraines and may be beneficial for depression. Another option is noninvasive Vagus Nerve Stimulation (nVNS), which has shown potential benefits in clinical trials for various conditions, including depression. Both TMS and nVNS are available in the United States and have been supported by clinical evidence for their effectiveness and safety.

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Behavioural Intervention

Non-Invasive Nerve Stimulation for Depression (MDD Trial)

N/A

Recruiting

Led By Linda Carpenter, MD

Research Sponsored by Neurolief Ltd.

Eligibility Criteria Checklist

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

Must have

Up to 36 randomized subjects aged 18-21

Current MDD episode lasts up to three years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks from treatment initiation

Summary

This trial is testing a self-administered device that stimulates nerves in the head to help patients with Major Depressive Disorder. The device sends gentle electrical signals to specific nerves, which may improve mood and reduce depression symptoms. Recent studies have shown that chronic electrical stimulation of brain reward areas induces a robust antidepressant effect.

Who is the study for?

This trial is for adults aged 18-70 with Major Depressive Disorder (MDD) who haven't had enough improvement from 1-4 antidepressant treatments. Participants must be able to use a smartphone and commit to the study requirements, including staying on their current antidepressant dose throughout the trial.

What is being tested?

The MOOD Study tests Relivion®DP, a noninvasive neurostimulation device for MDD treatment. It's a double-blind study comparing active treatment with a sham (placebo) control over an initial 8-week period followed by an open label phase where all receive active treatment for another 8 weeks.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort or skin irritation at electrode sites due to the nature of neurostimulation devices.

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 21 years old.

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My current episode of depression has lasted up to 3 years.

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The person has a score of 20 or more on the Hamilton Depression Rating Scale.

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Had a less than 50% response or no response to the treatment; the dose and duration were defined and rated at a minimum confidence level of 3 on the ATRF.

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I've tried 1-4 antidepressants without enough improvement or couldn't tolerate at least 2.

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I am taking an antidepressant and can keep the dose the same for at least 28 days.

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I am between 18 and 70 years old.

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I am between 22 and 70 years old.

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I have been diagnosed with major depression.

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My current episode of depression has lasted up to 3 years.

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I am currently experiencing a major depressive episode.

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I've tried 1-4 antidepressants without enough improvement.

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I can understand and agree to the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks from treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks from treatment initiation

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

Treatment Details

Study Objectives

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

Primary study objectives

Mean change in depressive symptoms, measured by HDRS17 total score

Secondary study objectives

Mean change in depressive symptoms, measured by MADRS total score

Proportion of responder subjects

Proportion of subjects achieving remission

Other study objectives

Mean Change in Quick Inventory of Depressive Symptomatology self-rated score

Mean Change in depressive symptoms severity and improvement scores

Mean change in depressive symptoms, measured by HDRS21 total score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 - active stimulationExperimental Treatment1 Intervention

Group II: Group 2 - sham stimulationPlacebo Group1 Intervention

0 / 15Eligibility 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

Common treatments for depression include pharmacotherapy, psychotherapy, and neuromodulation techniques. Pharmacotherapy often involves antidepressants like SSRIs and SNRIs, which work by increasing the levels of neurotransmitters such as serotonin and norepinephrine in the brain. Psychotherapy, such as Cognitive Behavioral Therapy (CBT), helps patients change negative thought patterns and behaviors. Neuromodulation techniques, including Transcranial Magnetic Stimulation (TMS) and the newer Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) studied in the Relivion®DP trial, aim to modulate brain activity through electrical or magnetic stimulation. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.

Huntington's disease: novel therapeutic perspectives hanging in the balance.International Union of Basic and Clinical Pharmacology CIV: The Neurobiology of Treatment-resistant Depression: From Antidepressant Classifications to Novel Pharmacological Targets.Measuring reinforcement learning and motivation constructs in experimental animals: relevance to the negative symptoms of schizophrenia.