iTBS for Increased Appetite Induced by Antipsychotics

December 20, 2023 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

60

Phase

  • 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 Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Central South University
        • Contact:
        • Principal Investigator:
          • Renrong Wu, Prof
        • Sub-Investigator:
          • 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

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, 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
Intervention / Treatment
Sham Comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Sham iTBS
MagPro X100
Active Comparator: active stimulation
Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Active iTBS
MagPro X100

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Changes in the Three-factor Eating Questionnaire (TFEQ)
Time Frame: Everyday from baseline to 4 weeks after treatment
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
Changes in the Food Cravings Questionnaire-Trait (FCQ-T)
Time Frame: Everyday from baseline to 4 weeks after 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.
Everyday from baseline to 4 weeks after treatment
Changes in the Food Cravings Questionnaire-State (FCQ-S)
Time Frame: Everyday from baseline to 4 weeks after treatment
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
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 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 brain function.
Time Frame: Baseline, after 5 treatment days and 4 weeks post-treatment
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
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

Collaborators and Investigators

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

Sponsor

Central South University

Investigators

  • 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)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU20221015

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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