Accelerated Versus Standard Intermittent Theta Burst Stimulation for Major Depressive Disorder
Recruiting · NCT07768397 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This randomized, rater-blinded clinical trial aims to compare the effectiveness, safety, and tolerability of accelerated intermittent theta burst stimulation (iTBS) with standard iTBS in adults with major depressive disorder (MDD). Participants will be randomly assigned in a 1:1 ratio to receive either accelerated or standard iTBS targeting the left dorsolateral prefrontal cortex. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. The accelerated iTBS group will receive 45 treatment sessions over approximately 15 treatment days, while the standard iTBS group will receive 20 treatment sessions over 4 weeks. The primary objective is to compare changes in depressive symptom severity, measured using the 17-item Hamilton Depression Rating Scale (HAM-D17), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, sleep quality, quality of life, cognitive measures, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).
Who can take part
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 is running
1 location listed.
- Military Hospital 175 - Ho Chi Minh City, Vietnam