Non-Invasive Nerve Stimulation for Depression (MDD Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen ByLinda Carpenter, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Neurolief Ltd.

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 21 years old.

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

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

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.

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

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

I am between 18 and 70 years old.

I am between 22 and 70 years old.

I have been diagnosed with major depression.

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

I am currently experiencing a major depressive episode.

Did not respond or have insufficiently responded by less than 50% improvement; dose and duration defined & rated at minimum confidence level 3 on the ATRF

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

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

Subject has cognitive and/or motor skills needed to operate a smartphone and can be contacted by phone, as determined by the Investigator

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 - active stimulationExperimental Treatment1 Intervention

Group II: Group 2 - sham stimulationPlacebo Group1 Intervention