Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Conventional high-frequency rTMS have been used to treat people with obesity and showed certain effectiveness. However, studies involving schizophrenia patients and intermittent theta burst (iTBS) mode are rarely seen. The goal of this clinical trial is to evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia.
The study will evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks after intervention. 60 schizophrenia patients will be randomized to receive active or sham interventions administered to the left dorsolateral prefrontal cortex. The experimental group will be applied to active iTBS rTMS involving 600 pulses (3 minutes), 5x daily at 60 minutes intervals for 5 days. Changes in appetite from baseline to the end of the study will be measured by Three Factor Eating Questionnaire (TFEQ), Food Cravings Questionnaire-Trait (FCQ-T), Food Cravings Questionnaire-State (FCQ-S) and Visual Analogue Scale (VAS). Clinical symptoms and mood status will be assessed by Positive and Negative Symptom Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and Clinical Global Impression (CGI). Improvement of cognition could be measured by Delay Discounting Task (DDT), Stop-signal task (SST) and MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB). Changes of appetite related Indicators of glycolipid metabolism and neuroregulatory factor, along with microflora before and after intervention will be recorded by collecting blood and feces specimens. The adverse effect will be evaluated by Treatment Emergent Symptom Scale (TESS) and Adverse Event Record Form (AERF). Task-based magnetic resonance imaging (MRI) and arterial spin labeling (ASL) will be used to measure changes of brain activity associated with food stimuli and cerebral blood flow(CBF) before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Mag-TD
Mag-TD
Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGThe Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China
RECRUITINGChanges in body mass index (BMI)
Weight gain will be assessed by BMI, caculated by weight in kilograms divided by height in meters squared
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in Positive and Negative Symptom Scale (PANSS)
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Time frame: Baseline and 4 weeks post-treatment
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Range from 0 to 27, higher score indicates more severe affective symptoms.
Time frame: Baseline and 4 weeks post-treatment
Changes in the Clinical Global Impressions (CGI)
The Clinical Global Impressions (CGI) scale, quantifying the severity of psychopathology, ranging from 1 to 7 and improvements, ranging from 1 to 7 after treatments
Time frame: Baseline and 4 weeks post-treatment
Changes in brain perfusion.
The arterial spin labeling (ASL) pulse sequences to quantify the cerebral blood flow (CBF).
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in brain function.
Functional MRI (fMRI) based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in MCCB
The MATRICS™ Consensus Cognitive Battery
Time frame: Baseline and 4 weeks post-treatment
Changes in SST.
Stop-signal task (SST) will be used to assess cognitive control.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in DDT.
Delay Discounting Task (DDT) will be used to assess impulsiveness in decision making.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Three-factor Eating Questionnaire (TFEQ)
TFEQ includes three domains, cognitive restraint, uncontrolled eating and emotional eating, range from 21 to 84, higher scores indicates higher appetite.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-Trait (FCQ-T)
Food Cravings Questionnaire-Trait (FCQ-T) is a six-point Likert scale to measure individuals' stable food craving traits containing nine factors with 39 items.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-State (FCQ-S)
The Food Cravings Questionnaire-State (FCQ-S) is a five-point Likert scale that measures the intensity of momentary food craving.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the visual analogue scale (VAS)
The visual analogue scale (VAS) will be used to assess the subjective sense of appetite covering hungry, satiety, desire to eat, and overeating, scoring from 0 = "not at all" to 10 = "extremely".
Time frame: Everyday from baseline to 4 weeks after treatment
Changes in the types of intestinal flora.
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Time frame: Baseline and 4 weeks post-treatment
Changes in plasma agouti related regulatory proteins.
in ng/mL.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum proopioid-melanocortin.
in ng/mL.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum ghrelin.
in ng/mL
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum leptin.
in ng/mL.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in the proportion of of intestinal flora.
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Time frame: Baseline and 4 weeks post-treatment
Changes in plasma prolactin.
in mcg/L.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total bile acids.
in mmol/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in glycosylated hemoglobin.
in mmol/mol.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum Low-density lipoprotein cholesterol.
in mg/dl.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum high-density lipoprotein cholesterol.
in mg/dl.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total cholesterol.
in mg/dl.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum triglycerides.
in mmol/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon-like peptide-1.
in pmol/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon.
in ng/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting insulin.
in mmol/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting blood glucose.
in mmol/l.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
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