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NCT06166082Completed

Intensive Accelerated iTBS for the Treatment-Resistant Depression

Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.

Status (registry)
Completed
Study type
Interventional
Enrollment
130 (actual)
First submitted
3 Dec 2023
Start date
22 Dec 2023
Primary completion date
21 Mar 2025
Lead sponsor
Changping Laboratory
Diseases
Depression
NCT number
NCT06166082

What you commit to

  • Study type: Interventional
  • Participants enrolled: 130
  • From 22 Dec 2023 to the primary completion date, 21 Mar 2025
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals with pacemakers, cochlear implants, or other metal objects, as well as any electronic devices implanted in the body, and those with claustrophobia Contraindications for magnetic resonance imaging scans such as fear, and contraindications for rTMS treatment;
  • History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold Syndromes, or seizures within the past 12 months;
  • Received TMS treatment before participating in the trial;
  • Individuals who have received ECT or phototherapy within three months;
  • Previously received antidepressant treatment with implanted devices (such as DBS, VNS);
  • Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
  • Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past year;
  • Current in clinical trials of other drugs or physical therapies (DBS, ECT, rTMS);

Other illness

  • Meets DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, and psychiatric disorders Developmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or other medical problems;
  • Complicated with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, which cause abnormal symptoms and signs of brain nerves, Or physical exhaustion;
  • First-degree relatives suffer from bipolar disorder;

Age

  • Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;

Other

  • No response to ECT treatment (\>8 times);
  • High risk of suicide;
  • Difficulty in communication to understand or follow instructions, and unable to cooperate with treatment and evaluation;
  • The researchers believe it is not suitable to participate.

Who the study is looking for

  • Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode;
  • Hamilton Depression Scale (HAMD-17) scores for 17 items ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score is ≥ 20 points;
  • hospitalized/outpatient patients aged ≥ 22 and ≤ 65 years old, male or female;
  • The Maudsley Staging Method (MSM) assesses patients as at least moderate refractory (MSM score ≥ 7 points);
  • Stable use of antidepressants for 4 weeks before randomization, with the type of antidepressant used being selective serotonin reuptake Selective serotonin reuptake inhibitors (SSRIs) or/and serotonin and norepinephrine reuptake Serotonin-norepinephrine reuptake inhibitors (SNRIs), the therapeutic dose is within the dosage range as the drug manual recommended;
  • Understand the trial and sign the informed consent form.

Age in the registry: 22 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hebei Mental Health Center
Coordinator of this site? Confirm its status
BaodingChinaUnknown status
HuiLongGuan Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Wuhan Mental Health Center
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Xianyue Hospital
Coordinator of this site? Confirm its status
XiamenChinaUnknown status
Zhumadian Second People's Hospital
Coordinator of this site? Confirm its status
ZhumadianChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.