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Can a faster brain stimulation schedule beat the standard for depression?

NCT ID NCT07768397

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This clinical trial is testing whether a faster, more intensive schedule of a brain stimulation treatment called intermittent theta burst stimulation (iTBS) works better than the standard schedule for adults with major depressive disorder. Participants will be randomly assigned to receive either accelerated iTBS (45 sessions over about 15 days) or standard iTBS (20 sessions over 4 weeks), in addition to their usual antidepressant medication. The main goal is to compare changes in depressive symptoms, measured by a standard rating scale, from the start to the end of treatment. The study will also look at other outcomes like cognitive function, quality of life, sleep, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intermittent theta burst stimulation (iTBS), a non-invasive brain stimulation technique, delivered in either an accelerated schedule (45 sessions over 15 days) or a standard schedule (20 sessions over 4 weeks), alongside usual antidepressant medication.
What this could lead to
If accelerated iTBS works better or works faster than the standard schedule, it could offer a quicker, more efficient treatment option for people with major depressive disorder.
What could go wrong
This is a mid-sized trial (80 people), and results may not apply to everyone. The accelerated schedule is more intensive, which could lead to more side effects or discomfort, and it's not yet known if it will prove more effective than the standard approach.

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

About 80 people

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

Started

Aug 2026

Expected to finish

Jun 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 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: * Age 18 to 65 years. * Right-handed. * Diagnosis of major depressive disorder according to ICD-10 criteria (F32 or F33), confirmed by a psychiatrist. * 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥18 at screening/baseline. * Able and willing to provide written informed consent and comply with essential study procedures. * Participants may be psychotropic-medication naïve or may be receiving psychotropic medication. Participants currently receiving psychotropic medication must have maintained the same medication(s) and dose(s) for at least 2 weeks before randomization; for fluoxetine, the required stable period is at least 4 weeks. Exclusion Criteria: * Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI. * Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator. * Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels. * Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures. * History of epilepsy or seizures, except febrile seizures in childhood. * Bipolar disorder. * Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders. * Acute suicide risk, defined as a score ≥3 on item 3 of the HAM-D17 or clear suicidal ideation or behavior. * Alcohol or substance abuse or dependence within the previous 6 months. * A medical condition associated with a high seizure risk or a history of cranial surgery. * Current use of medication judged by the screening physician to substantially increase seizure risk, or rapid reduction/discontinuation of benzodiazepines, antiseizure medications, or other centrally acting medications associated with withdrawal or increased seizure risk. * Serum vitamin D level \<20 ng/mL that has not been adequately corrected. * Elevated C-reactive protein associated with clinically significant acute infection or acute inflammatory illness that, in the investigator's judgment, may affect participant safety or study outcome assessment. * Pregnant or breastfeeding. * Unable to understand or complete essential study procedures. Participants with potentially reversible temporary exclusion conditions may be rescreened once the condition has been adequately corrected or clinically stabilized.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Military Hospital 175

    RECRUITING

    Ho Chi Minh City, 700000, Vietnam

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