Accelerated vs Standard iTBS for Major Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, rater-blinded trial compares accelerated intermittent theta burst stimulation (iTBS) to standard iTBS in adults with major depressive disorder. Participants are randomized 1:1 to receive either 45 accelerated sessions over about 15 days or 20 standard sessions over 4 weeks, with some participants continuing stable psychotropic medications. The primary outcome is change in depressive symptoms measured by HAM-D17 from baseline to end of treatment; secondary outcomes include response and remission rates, safety, and tolerability. The study allows medication-naïve individuals or those on stable psychotropic regimens per protocol-defined criteria. Treatments target the left dorsolateral prefrontal cortex using iTBS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Military Hospital 175
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Study coordinator: Dang Minh Ly, MD
• Email: drminhdang@outlook.com
• Phone: +84359999741

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.