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Recruiting NCT05783063

iTBS for Increased Appetite Induced by Antipsychotics

No phase Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active iTBS, Sham iTBS.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Active iTBS
    Mag-TD
  • Device Sham iTBS
    Mag-TD

Primary outcome measures

  • Changes in body mass index (BMI) [Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
Secondary outcome measures (12)
  • Changes in Positive and Negative Symptom Scale (PANSS) [Time frame: Baseline and 4 weeks post-treatment]
  • Changes in Calgary Depression Scale for Schizophrenia (CDSS) [Time frame: Baseline and 4 weeks post-treatment]
  • Changes in the Clinical Global Impressions (CGI) [Time frame: Baseline and 4 weeks post-treatment]
  • Changes in brain perfusion. [Time frame: 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]
  • Changes in MCCB [Time frame: Baseline and 4 weeks post-treatment]
  • Changes in SST. [Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
  • Changes in DDT. [Time frame: Baseline, after 5 treatment days, 2 weeks 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]
  • Changes in the Food Cravings Questionnaire-Trait (FCQ-T) [Time frame: 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]
  • Changes in the visual analogue scale (VAS) [Time frame: Everyday from baseline to 4 weeks after treatment]

Eligibility criteria

Inclusion criteria

  • Age between 18-40 years old;
  • Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);
  • BMI ≥ 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;
  • Not receiving TMS therapy in the past month;
  • 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;
  • Signing written informed consents voluntarily.

Exclusion criteria

  • Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;
  • Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;
  • Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;
  • Suicidal thoughts or behaviors;
  • Alcohol or substance abuse;
  • Pregnant or lactating women;
  • Other contraindications of MRI;
  • Receiving regular MECT, or weight-loss therapy in the latest month;
  • Other abnormal examination results considered to be inappropriate for inclusion by researchers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Central South University — Changsha
  • The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali

Publications

  • Qin Y, Yang J, Xu B, Yang J, Chen H, Zou T, Teng Z, Liu J, Zhang T, Su Y, Wu R, Dong Z, Yang C, Huang J. Effects of intermittent theta burst stimulation (iTBS) on appetite change and body weight in inpatients with schizophrenia in China: study protocol for a randomised controlled trial. BMJ Open. 2025 Apr 8;15(4):e090932. doi: 10.1136/bmjopen-2024-090932. PMID 40204331

Identifiers

NCT: NCT05783063 · WU20221015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗