The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Treatment-resistance Depression： a Randomized， Double-Blind， Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Moderate Depression
- Sponsor
- Changping Laboratory
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders.
Detailed Description
In 2022, the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression (TRD), which requires 10 sessions per day of 1,800 pulses per session for a total of 18,000 pulses per day. The inter-session interval is 50 min, and it costs patients 9 hours for the intervention. The investigators assume that patients with moderate to severe depression may not need 10 sessions per day, patients may achieve response or remission with a less amount of dosage, which will save the cost of treatment. Hence, the investigators try to find the optimal treatment dosage for patients with moderate to severe depression. After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- •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.
- •Total HAMD-17 score ≥20 and MADRS ≥20 before randomization.
- •The Maudsley Staging Method (MSM) is used to assess patients as having at least a moderate level of treatment-resistant condition (MSM score ≥ 7 points).
- •Participants currently are on stable drug use for at least 4 weeks before randomization. Antidepressants used are selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Combined use of two types of antidepressants is allowed.
- •Voluntarily participate in the trial and able to provide informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
Exclusion Criteria
- •Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
- •Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
- •Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
- •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;
- •History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
- •Currently receiving or plan to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial;
- •Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
- •Female of childbearing potential who plans to become pregnant during the trial.
- •Female that is pregnant or breastfeeding.
- •Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
Outcomes
Primary Outcomes
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
Time Frame: Baseline, Day 5(Immediate Post-treatment)
The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
Secondary Outcomes
- Change in MADRS(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment)
- cognitive change in Digit Symbol Substitution Test (DSST）(Baseline, Day 5)
- Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment)
- Safety estimated using SSI, YMRS(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment)
- cognitive change in continuous performance test (CPT）(Baseline, Day 5)
- Change in Hamilton Depression Scale (HAMD-17)(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment)
- cognitive change in Trail-Making Test (TMT)(Baseline, Day 5)
- cognitive change in Digit Span Test (DST)(Baseline, Day 5)