iTBS for Increased Appetite Induced by Antipsychotics

NCT ID: NCT05783063

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-08-01

Brief 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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active stimulation

Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.

Group Type: ACTIVE_COMPARATOR

Active iTBS

Intervention Type: DEVICE

Mag-TD

Sham stimulation

Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.

Group Type: SHAM_COMPARATOR

Sham iTBS

Intervention Type: DEVICE

Mag-TD

Interventions

Active iTBS

Mag-TD

Intervention Type: DEVICE

Sham iTBS

Mag-TD

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Deputy Director of the Department of Psychiatry, the Second Xiangya Hospital of Central South University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renrong Wu, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, The Second Xiangya Hospital of Central South University

Locations

Central South University

Changsha, Hunan, China

Site Status: NOT_YET_RECRUITING

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Renrong Wu, M.D. Ph.D

Role: CONTACT

wurenrong@csu.edu.cn

+8615874179855

Jing Huang, M.D. Ph.D

Role: CONTACT

jinghuangserena@csu.edu.cn

15874290980

Facility Contacts

Renrong Wu, Prof

Role: primary

wurenrong@csu.edu

+86 158 741 79855

Jin Yang, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40204331 (View on PubMed)

Other Identifiers

WU20221015

Identifier Type: -

Identifier Source: org_study_id