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Nerve zapping study reveals sex differences in depression stress response

NCT ID NCT04448327

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study looked at how a gentle nerve stimulation device (tVNS) affects stress-related brain activity and body functions in people with major depression. Researchers compared active stimulation to a sham (fake) version in 62 adults, focusing on differences between men and women. The goal was to understand how the treatment works, not to test a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Jan 2021

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Current or past diagnosis of recurrent Major Depressive Disorder Exclusion Criteria: * History of neuroleptic use * Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar I disorder) * Active suicidal ideation with intent and/or plan or history of a suicide attempt within the last year * Moderate or severe substance use disorder within the past 12 months * Diagnosis of significant cardiovascular or cerebrovascular disease (e.g. congestive heart failure, stroke, cardiac conduction disorders, history of asystole or non-sustained ventricular tachycardia) * Diseases affecting the CNS (e.g. MS, epilepsy, neurodegenerative diseases, etc.) * Traumatic brain injury with cognitive sequelae * MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices) * Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • Massachusetts General Hospital

    Charlestown, Massachusetts, 02129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.