iTBS for Increased Appetite Induced by Antipsychotics

Schizophrenia Clinical Trial

Official title:

Effects of Intermittent Theta Burst Stimulation (iTBS) on Increased Appetite Induced by Antipsychotics in Patients With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783063
• Other study ID #: WU20221015
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Central South University
• Contact: Renrong Wu, M.D. Ph.D
• Phone: +8615874179855
• Email: wurenrong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age between 18-40 years old;

2. Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);

3. BMI = 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;

4. Not receiving TMS therapy in the past month;

5. Using no more than two antipsychotic medications, not using antidepressants, mood stabilizers and other drugs, but allowing short-term use of benzodiazepines, benzhexol and propranolol;

6. Signing written informed consents voluntarily.

Exclusion Criteria:

1. Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;

2. Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;

3. Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;

4. Suicidal thoughts or behaviors;

5. Alcohol or substance abuse;

6. Pregnant or lactating women;

7. Other contraindications of MRI;

8. Receiving regular MECT, or weight-loss therapy in the latest month;

9. Other abnormal examination results considered to be inappropriate for inclusion by researchers.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Active iTBS
MagPro X100
• Sham iTBS
MagPro X100

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan
China	The Second People's Hospital of Dali Bai Autonomous Prefecture	Dali	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in brain perfusion.	The arterial spin labeling (ASL) pulse sequences to quantify the cerebral blood flow (CBF).	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in brain function.	Functional MRI (fMRI) based on a task of visual processing appetitive stimuli to analyze the change of brain function after intervention.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum fasting blood glucose.	in mmol/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum fasting insulin.	in mmol/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum glucagon.	in ng/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum glucagon-like peptide-1.	in pmol/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum triglycerides.	in mmol/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum total cholesterol.	in mg/dl.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum high-density lipoprotein cholesterol.	in mg/dl.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum Low-density lipoprotein cholesterol.	in mg/dl.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in glycosylated hemoglobin.	in mmol/mol.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in serum total bile acids.	in mmol/l.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in SST.	Stop-signal task (SST) will be used to assess cognitive control.	Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Other	Changes in DDT.	Delay Discounting Task (DDT) will be used to assess impulsiveness in decision making.	Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Other	Changes in plasma prolactin.	in mcg/L.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in plasma serum leptin.	in ng/mL.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in plasma serum ghrelin.	in ng/mL	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in plasma serum proopioid-melanocortin.	in ng/mL.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in plasma agouti related regulatory proteins.	in ng/mL.	Baseline, after 5 treatment days and 4 weeks post-treatment
Other	Changes in the types of intestinal flora.	Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.	Baseline and 4 weeks post-treatment
Other	Changes in the proportion of of intestinal flora.	Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.	Baseline and 4 weeks post-treatment
Other	Changes in MCCB	The MATRICS™ Consensus Cognitive Battery	Baseline and 4 weeks post-treatment
Primary	Changes in body mass index (BMI)	Weight gain will be assessed by BMI, caculated by weight in kilograms divided by height in meters squared	Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Secondary	Changes in Positive and Negative Symptom Scale (PANSS)	Range from 30 to 210, higher score indicates more severe positive and negative symptoms.	Baseline and 4 weeks post-treatment
Secondary	Changes in Calgary Depression Scale for Schizophrenia (CDSS)	Range from 0 to 27, higher score indicates more severe affective symptoms.	Baseline and 4 weeks post-treatment
Secondary	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	Baseline and 4 weeks post-treatment
Secondary	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.	Everyday from baseline to 4 weeks after treatment
Secondary	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.	Everyday from baseline to 4 weeks after treatment
Secondary	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.	Everyday from baseline to 4 weeks after treatment
Secondary	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".	Everyday from baseline to 4 weeks after treatment