Stanford Neuromodulation Therapy for Treatment-Resistant Depression

Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression: A Study Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial

This study is testing if a new therapy called Stanford Neuromodulation Therapy can help people with treatment-resistant depression feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 5 sites (Baoding and 4 other locations)
• Trial ID: NCT06166082 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, and sham-controlled trial aims to evaluate the efficacy of Stanford Neuromodulation Therapy (SNT) for patients with treatment-resistant depression (TRD). Participants will be randomly assigned to receive either active or sham treatment over a 5-day period, with follow-up assessments conducted for 8 weeks. The therapy involves high-dose intermittent theta burst stimulation (iTBS) targeting the dorsolateral prefrontal cortex, guided by resting-state functional MRI. The study seeks to replicate previous findings that demonstrated significant antidepressant effects of SNT.

Who should consider this trial

Good fit: Ideal candidates include adults aged 22 to 65 with a diagnosis of major depressive disorder experiencing a recurrence episode and meeting specific severity criteria.

Not a fit: Patients with psychotic symptoms or those who do not meet the criteria for treatment-resistant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide rapid relief from depressive symptoms for patients with treatment-resistant depression.

How similar studies have performed: Previous studies have shown promising results with similar neuromodulation approaches, but this specific application of SNT is being further validated in a larger multicenter setting.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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;
* No response to ECT treatment (\>8 times);
* 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;
* 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;
* Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
* Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past year;
* First-degree relatives suffer from bipolar disorder;
* High risk of suicide;
* Difficulty in communication to understand or follow instructions, and unable to cooperate with treatment and evaluation;
* Current in clinical trials of other drugs or physical therapies (DBS, ECT, rTMS);
* The researchers believe it is not suitable to participate.

Where this trial is running

Baoding and 4 other locations

• Hebei Mental Health Center — Baoding, China (Recruiting)
• HuiLongGuan Hospital — Beijing, China (Recruiting)
• Wuhan Mental Health Center — Wuhan, China (Recruiting)
• Xianyue Hospital — Xiamen, China (Recruiting)
• Zhumadian Second People's Hospital — Zhumadian, China (Recruiting)

Study contacts

• Study coordinator: Meiling Li, Ph.D.

Conditions Treatment Resistant Depression; TRD