Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression

Launched by CHANGPING LABORATORY · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called Stanford Neuromodulation Therapy (SNT) for people who have treatment-resistant depression, meaning they haven't found relief from their symptoms with standard antidepressant medications. The study will involve participants from five hospitals in China, who will be randomly assigned to receive either the active SNT treatment or a placebo (a treatment that looks the same but has no real effect) over a period of five days. Both groups will be monitored for eight weeks afterward to see how they respond. The aim is to determine if SNT can effectively help those struggling with severe depression.

To participate in this trial, individuals need to be between 22 and 65 years old and have a specific type of depression, confirmed by a mental health professional. They must also have been consistently taking certain antidepressants for at least four weeks before joining the study. Participants will have regular check-ins during the trial to track their progress. It's important to note that those with certain medical conditions, previous treatments, or specific mental health issues may not be eligible to participate, as these factors could affect the study's results.

Gender

ALL

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.