ITBS for Increased Appetite Induced by Antipsychotics

March 22, 2025 updated by: Renrong Wu, Central South University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Central South University
        • Contact:
        • Contact:
          • Renrong Wu, Prof
        • Contact:
          • Jing Huang, M.D.
    • Yunnan
      • Dali, Yunnan, China, 671014
        • Recruiting
        • The Second People's Hospital of Dali Bai Autonomous Prefecture
        • Contact:
          • Jin Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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 (including olanzapine, haloperidol, amisulpride, asenapine, risperidone, paliperidone, clozapine, quetiapine, iloperidone, chlorpromazine, sertindole, zotepine), 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Sham iTBS
Mag-TD
Active Comparator: active stimulation
Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Active iTBS
Mag-TD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in body mass index (BMI)
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the visual analogue scale (VAS)
Time Frame: Everyday from baseline to 4 weeks after treatment
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
Changes in SST.
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Stop-signal task (SST) will be used to assess cognitive control.
Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in Positive and Negative Symptom Scale (PANSS)
Time Frame: Baseline and 4 weeks post-treatment
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Baseline and 4 weeks post-treatment
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Baseline and 4 weeks post-treatment
Range from 0 to 27, higher score indicates more severe affective symptoms.
Baseline and 4 weeks post-treatment
Changes in the Clinical Global Impressions (CGI)
Time Frame: Baseline and 4 weeks post-treatment
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
Changes in brain perfusion.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
The arterial spin labeling (ASL) pulse sequences to quantify the cerebral blood flow (CBF).
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting blood glucose.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting insulin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon-like peptide-1.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in pmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum triglycerides.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum high-density lipoprotein cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum Low-density lipoprotein cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in glycosylated hemoglobin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/mol.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total bile acids.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in DDT.
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
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
Changes in plasma prolactin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mcg/L.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum leptin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum ghrelin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum proopioid-melanocortin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma agouti related regulatory proteins.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in the types of intestinal flora.
Time Frame: Baseline and 4 weeks post-treatment
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Baseline and 4 weeks post-treatment
Changes in the proportion of of intestinal flora.
Time Frame: Baseline and 4 weeks post-treatment
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Baseline and 4 weeks post-treatment
Changes in MCCB
Time Frame: Baseline and 4 weeks post-treatment
The MATRICS™ Consensus Cognitive Battery
Baseline and 4 weeks post-treatment
Changes in the Three-factor Eating Questionnaire (TFEQ)
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
TFEQ includes three domains, cognitive restraint, uncontrolled eating and emotional eating, range from 21 to 84, higher scores indicates higher appetite.
Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-Trait (FCQ-T)
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
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.
Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-State (FCQ-S)
Time Frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
The Food Cravings Questionnaire-State (FCQ-S) is a five-point Likert scale that measures the intensity of momentary food craving.
Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in brain function.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
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.
Baseline, after 5 treatment days and 4 weeks post-treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in serum fasting blood glucose.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting insulin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon-like peptide-1.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in pmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum triglycerides.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum high-density lipoprotein cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum Low-density lipoprotein cholesterol.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mg/dl.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in glycosylated hemoglobin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/mol.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total bile acids.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mmol/l.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma prolactin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in mcg/L.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum leptin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum ghrelin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum proopioid-melanocortin.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma agouti related regulatory proteins.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
in ng/mL.
Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in the types of intestinal flora.
Time Frame: Baseline and 4 weeks post-treatment
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Baseline and 4 weeks post-treatment
Changes in the proportion of of intestinal flora.
Time Frame: Baseline and 4 weeks post-treatment
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Baseline and 4 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Renrong Wu, M.D. Ph.D, Department of Psychiatry, the Second Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WU20221015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data Sharing Plan The proposed study will involve a small sample (60 patients with schizophrenia) recruited from clinical institutions of the Second People's Hospital of Dali Bai Autonomous Prefecture and the Second Xiangya Hospital of Central South University in China. The final dataset will comprise self-reported demographic and clinical characteristics, behavioral and neuroimaging data, along with laboratory data from blood and stool specimens provided by the participants. Because schizophrenia is a reportable severe mental disorder, identifying information will be collected. Although the final dataset is deidentified before it is released for sharing, we believe it is still possible to infer the disclosure of subjects with psychotic characteristics. Patients with schizophrenia belong to a vulnerable group, often accompanied by a sense of stigma. Given the social distress of the participants and the relatively limited area in which we recruited the participants, we thought it would

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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