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NCT07559084
Multi-target TMS for Schizophrenia Negative Symptoms
Conditions: SCHIZOPHRENIA 1 (Disorder)
Sex: All
Ages: 16 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Shanghai Mental Health Center
Location: Shanghai Mental Health Center Shanghai Shanghai Municipality
Summary
This randomized controlled trial (RCT) is the first to evaluate the efficacy and safety of a multi-target TMS protocol targeting the right orbitofrontal cortex (R-OFC), left dorsolateral prefrontal cortex (L-DLPFC), and left inferior parietal lobule (L-IPL) for negative symptoms of schizophrenia.
Eligibility Criteria
Inclusion Criteria:
1. Outpatients or inpatients at the Department of Psychiatry, Shanghai Mental Health Center;
2. Meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for first-episode schizophrenia (diagnosed using the Structured Clinical Interview for DSM-5, SCID-5); disease duration less than 5 years at enrollment;
3. Male or female aged 16-45 years;
4. Education duration ≥ 9 years;
5. Stable medication regimen for at least 6 weeks prior to baseline visit and throughout the study period; psychiatric symptoms generally stable within 1 month prior to baseline visit;
6. Participants and their guardians can understand and sign written informed consent;
7. Total score on the PANSS Negative Symptom subscale (PANSS-N) \> 15, and at least one item score ≥ 3.
Exclusion Criteria:
1. Current or lifetime psychiatric disorders as determined by SCID-5 assessment;
2. Severe or unstable physical illnesses, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension, hyperglycemia, malignant tumors, and immunocompromised conditions;
3. Alcohol abuse within 30 days prior to the study or alcohol/drug dependence within 6 months prior to the study; participation in any clinical trial within 30 days prior to baseline;
4. Pregnant or breastfeeding women;
5. Intellectual disability (IQ \< 70);
6. No history of modified electroconvulsive therapy (mECT) within the past 6 months.
Source: ClinicalTrials.gov (NCT07559084). StuddyBuddy aggregates publicly available trial information.