Schizophrenia
Conditions
Keywords
Schizophrenia, rTMS, Appetite, Cognitive Function
Brief summary
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
Detailed description
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.
Interventions
DEVICEiTBS
Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total.
DEVICEShame stimulation
TMS coil vertical to the brain surface, with same protocol as iTBS
Sponsors
Shanghai Mental Health Center
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia in accordance with DSM-5 * Commorbid with significant weight gain after antipsychotics * Informed Consent
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 |
|---|---|---|
| Change of Appetite | Change from Baseline to 6days and 36days | Three-Factor Eating Questionnaire |
| Change of MCCB | Change from Baseline to 6days and 36days | The MATRICS™ Consensus Cognitive Battery |
| Change of ERP | Change from Baseline to 6days and 36days | Food picture ERP recorded by EEG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Total Cholesterol | Change from Baseline to 6days and 36days | in mmol/l |
| Change of LDL | Change from Baseline to 6days and 36days | in mmol/l |
| Change of fasting glucose | Change from Baseline to 6days and 36days | in mmol/l |
| Change of BMI | Change from Baseline to 6days and 36days | weight and height will be combined to report BMI in kg/m\^2 |
| Change of HDL | Change from Baseline to 6days and 36days | in mmol/l |
| Change of fasting insulin level | Change from Baseline to 6days and 36days | in mmol/l |
| Change of Triglyceride | Change from Baseline to 6days and 36days | in mmol/l |
Countries
China
Outcome results
None listed