Clinical trial NCT05086133: cTBS on First-episode Drug Naive Patients With Schizophrenia
Official title: The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2021-10-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 group for intervention and 1 group for sham stimulation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Three-Factor Eating Questionnaire
timeFrame: Change from Baseline to 6days and 36days
measure: MCCB
timeFrame: Change from Baseline to 6days and 36days
measure: The positive and negative syndrome scale
timeFrame: Change from Baseline to 6days and 36days
measure: BMI
timeFrame: Change from Baseline to 6days and 36days
Secondary outcomes:
measure: Resting EEG
timeFrame: Change from Baseline to 6days and 36days
measure: fasting glucose
timeFrame: Change from Baseline to 6days and 36days
measure: Triglyceride
timeFrame: Change from Baseline to 6days and 36days
measure: Total Cholesterol
timeFrame: Change from Baseline to 6days and 36days
measure: Low Density Lipoprotein
timeFrame: Change from Baseline to 6days and 36days
measure: High Density Lipoprotein
timeFrame: Change from Baseline to 6days and 36days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
References: