- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06166082
Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression
Stanford Neuromodulation Therapy (SNT) for the Treatment-Resistant Depression: A Study Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meiling Li, Ph.D.
- Phone Number: 010-80726688
- Email: meilingli@cpl.ac.cn
Study Locations
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Baoding, China
- Recruiting
- Hebei Mental Health Center
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Contact:
- Lili Zhang
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Principal Investigator:
- Keqing Li
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Beijing, China
- Recruiting
- HuiLongGuan Hospital
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Contact:
- Song Chen
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Principal Investigator:
- Baopeng Tian
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Wuhan, China
- Recruiting
- Wuhan Mental Health Center
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Principal Investigator:
- Yi Li
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Contact:
- Aohan Bai
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Xiamen, China
- Recruiting
- Xianyue Hospital
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Contact:
- Zhenhua Liao
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Principal Investigator:
- Jindong Chen
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Zhumadian, China
- Recruiting
- Zhumadian Second People's Hospital
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Contact:
- Hongwei Zhang
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Sub-Investigator:
- Lvfeng Zhang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active iTBS-DLPFC
The active group will receive active iTBS.
Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals.
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Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.
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Sham Comparator: Sham iTBS-DLPFC
The sham group will receive sham iTBS.
Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals.
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The parameters in the sham arms are the same as the active stimulation groups.
Stimulation was delivered by the same device as the active group fitted with a sham coil.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Pretreatment (baseline), 28 days post-treatment
|
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
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Pretreatment (baseline), 28 days post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in MADRS
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 56 days Post-treatment]
|
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
|
Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 56 days Post-treatment]
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Change in the Hamilton Rating Scale for Depression (HAMD-17)
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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A provider administered questionnaire used to assess remission and recovery from depression.
The HAMD-17 is a 17-item questionnaire to assess depression severity.
Each item is scored from 0-4, with higher scores representing increasing depression severity.
|
Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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Change in the Hamilton Rating Scale for Depression (HAMD-6) Score
Time Frame: Baseline, Day 1, 2, 3, 4 in treatment, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-6 version consists of 6 items assessing for: mood, guilt, general somatic symptoms, work and activities, anxiety and slowness of thought and speech). Each item is scored on a scale of 0 to 4, except for the somatic symptoms item, which is scored 0 to 2. On the HAM-6 there can be a total score of 22. Higher scores represent higher depression severity. Here, we report a count of participants with an overall increase, decrease or no change in total HAM-6 score. Participants with an increase in total score (row 3) would signify a worse outcome than participants with a decrease in total score. |
Baseline, Day 1, 2, 3, 4 in treatment, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)
Time Frame: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders.
Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity.
|
Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
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Safety estimated using YMRS
Time Frame: Baseline, Day 5 (Immediate Post-treatment)
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Young Mania Rating Scale(YMARS) measures mania
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Baseline, Day 5 (Immediate Post-treatment)
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cognitive change in Digit Symbol Substitution Test (DSST)
Time Frame: Baseline, Day 5(Immediate Post-treatment)
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Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
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Baseline, Day 5(Immediate Post-treatment)
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cognitive change in continuous performance test (CPT)
Time Frame: Baseline, Day 5(Immediate Post-treatment)
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CPT from the C-BCT measures a person's sustained and selective attention
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Baseline, Day 5(Immediate Post-treatment)
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cognitive change in Trail-Making Test (TMT)
Time Frame: Baseline, Day 5(Immediate Post-treatment)
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The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
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Baseline, Day 5(Immediate Post-treatment)
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cognitive change in Digit Span Test (DST)
Time Frame: Baseline, Day 5(Immediate Post-treatment)
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DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span
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Baseline, Day 5(Immediate Post-treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hesheng Liu, Ph.D., Changping Laboratory
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPLSNT_Multicenter
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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