Schizophrenia
Conditions
Brief summary
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
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.
Interventions
DEVICEtranscranial magnetic stimulation
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
DEVICEsham stimulation
TMS coil vertical to the brain surface, with same protocol as cTBS
Sponsors
Shanghai Mental Health Center
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.
Intervention model description
1 group for intervention and 1 group for sham stimulation
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Three-Factor Eating Questionnaire | Change from Baseline to 6days and 36days | min value 21, max value 84. The higher scores mean more unhealthy eating behavior. |
| MCCB | Change from Baseline to 6days and 36days | The MATRICS™ Consensus Cognitive Battery |
| The positive and negative syndrome scale | Change from Baseline to 6days and 36days | min score 30, max score 210. The higher score means more severe symptoms. |
| BMI | Change from Baseline to 6days and 36days | body mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Density Lipoprotein | Change from Baseline to 6days and 36days | in mmol/l |
| Resting EEG | Change from Baseline to 6days and 36days | resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated. |
| High Density Lipoprotein | Change from Baseline to 6days and 36days | in mmol/l |
| fasting glucose | Change from Baseline to 6days and 36days | in mmol/l |
| Triglyceride | Change from Baseline to 6days and 36days | in mmol/l |
| Total Cholesterol | Change from Baseline to 6days and 36days | in mmol/l |
Countries
China
Outcome results
None listed