Clinical trial NCT04714970: rTMS on Appetite and Cognitive Function in Schizophrenia
Official title: Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
rTMS
Appetite
Cognitive Function
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
First posted: 2021-01-20
Enrollment: 10
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: 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Appetite
timeFrame: Change from Baseline to 6days and 36days
measure: Change of MCCB
timeFrame: Change from Baseline to 6days and 36days
measure: Change of ERP
timeFrame: Change from Baseline to 6days and 36days
Secondary outcomes:
measure: Change of fasting glucose
timeFrame: Change from Baseline to 6days and 36days
measure: Change of fasting insulin level
timeFrame: Change from Baseline to 6days and 36days
measure: Change of Triglyceride
timeFrame: Change from Baseline to 6days and 36days
measure: Change of Total Cholesterol
timeFrame: Change from Baseline to 6days and 36days
measure: Change of LDL
timeFrame: Change from Baseline to 6days and 36days
measure: Change of HDL
timeFrame: Change from Baseline to 6days and 36days
measure: Change of BMI
timeFrame: Change from Baseline to 6days and 36days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Central South University
state: Hunan
Study officials:
affiliation: Central South University Psychiatry Department
name: Renrong Wu, Prof
role: PRINCIPAL_INVESTIGATOR
References: