Status:
UNKNOWN
Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression
Lead Sponsor:
Changping Laboratory
Collaborating Sponsors:
Xianyue Hospital, Xiamen
Hebei Mental Health Center, Baoding
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
This study is a multicenter, randomized, double-blind, and sham-controlled trial using the identical protocol as the SNT to replicate the antidepressant efficacy of SNT for TRD. Patients will be recru...
Detailed Description
Repetitive Transcranial Magnetic Training (rTMS) is a non-invasive neuromodulation that has been approved by the Food and Drug Administration (FDA) for treating patients with treatment-resistant depre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06166082
Start Date
December 22 2023
End Date
October 31 2024
Last Update
February 6 2024
Active Locations (5)
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1
Hebei Mental Health Center
Baoding, China
2
HuiLongGuan Hospital
Beijing, China
3
Wuhan Mental Health Center
Wuhan, China
4
Xianyue Hospital
Xiamen, China