cTBS on First-episode Drug Naive Patients With Schizophrenia

Study Overview
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Brief Summary
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cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Detailed Description
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cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Official Title
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The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: transcranial magnetic stimulation
* Device: sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with schizophrenia in accordance with DSM-5 The course of the disease less then 2 years Accepting antipsychotics treatment for less then 2 months Exclusion Criteria: Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before Drug or alcohol abuse Pregnant or lactating Contraindication to rTMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 group for intervention and 1 group for sham stimulation
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cTBS stimulation<br>The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. | Device: transcranial magnetic stimulation<br>* transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.<br>|
| Sham Comparator: Sham stimulation<br>The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. | Device: sham stimulation<br>* TMS coil vertical to the brain surface, with same protocol as cTBS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-Factor Eating Questionnaire | min value 21, max value 84. The higher scores mean more unhealthy eating behavior. | Change from Baseline to 6days and 36days | 
| MCCB | The MATRICS™ Consensus Cognitive Battery | Change from Baseline to 6days and 36days | 
| The positive and negative syndrome scale | min score 30, max score 210. The higher score means more severe symptoms. | Change from Baseline to 6days and 36days | 
| BMI | body mass index | Change from Baseline to 6days and 36days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting EEG | resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated. | Change from Baseline to 6days and 36days | 
| fasting glucose | in mmol/l | Change from Baseline to 6days and 36days | 
| Triglyceride | in mmol/l | Change from Baseline to 6days and 36days | 
| Total Cholesterol | in mmol/l | Change from Baseline to 6days and 36days | 
| Low Density Lipoprotein | in mmol/l | Change from Baseline to 6days and 36days | 
| High Density Lipoprotein | in mmol/l | Change from Baseline to 6days and 36days |