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Tailored brain zaps aim to lift severe depression

NCT ID NCT06784388

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a personalized approach to deep brain stimulation (DBS) for people with depression that hasn't improved with other treatments. Researchers use brain scans and recordings to find the best spot and settings for each person's implant. The goal is to see if this tailored method can safely reduce depression symptoms and identify brain signals linked to mood.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

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

18 to 70 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: 1. A psychiatrist-confirmed diagnosis of major depressive disorder in accordance with the Diagnostic And Statistical Manual Of Mental Disorders.5th Ed (DSM-V); 2. A psychiatric examination by two trained psychiatrists and a diagnosis consistent with the DSM-V; 3. A history of depression of at least 12 months duration in depressed patients (including MECT) who have failed to respond to a full dose and course of treatment with 2 or more antidepressants of different mechanisms; 4. A 17-item score on the HAMD scale ⩾ 20 at initial screening; 5. A score of ≤ 50 on the Gross Assessment of Functioning (GAF) scale; 6. The patient himself/herself or legal guardian was able to fully understand the therapy and agreed to enroll after signing an informed consent form. Exclusion Criteria: 1. Persons with severe or unstable cardiac, hepatic, renal, endocrine, hematologic, and other medical disorders and co-morbidities with psychotic symptoms, including personality disorders diagnosed by history, questioning, and clinical examination; 2. Persons with psychiatric disorders other than depression (except generalized anxiety); 3. Persons with a history of substance abuse within 12 months; persons with a previous history of epilepsy, and persons with febrile convulsions in childhood; 4. Patients with a history of suicide attempts within the past 6 months or more than 2 suicide attempts within the past 2 years; 5. Women who are breastfeeding, pregnant, and patients who are pregnant or intend to become pregnant during the clinical study; 6. Contraindications to DBS surgery and MRI; 7. Years of education less than or equal to 9 years; 8. Patients who are involuntarily hospitalized.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

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

Treatment resistant depression (TRD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

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