NCT05783063

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
3mo left

Started Aug 2023

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

February 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

February 28, 2023

Last Update Submit

March 22, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaappetiteweightantipsychoticsiTBS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (29)

  • Changes in Positive and Negative Symptom Scale (PANSS)

    Baseline and 4 weeks post-treatment

  • Changes in Calgary Depression Scale for Schizophrenia (CDSS)

    Baseline and 4 weeks post-treatment

  • Changes in the Clinical Global Impressions (CGI)

    Baseline and 4 weeks post-treatment

  • Changes in brain perfusion.

    Baseline, after 5 treatment days and 4 weeks post-treatment

  • Changes in brain function.

    Baseline, after 5 treatment days and 4 weeks post-treatment

  • +24 more secondary outcomes

Study Arms (2)

active stimulation

ACTIVE COMPARATOR

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

Device: Active iTBS

Sham stimulation

SHAM COMPARATOR

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

Device: Sham iTBS

Interventions

Active iTBSDEVICE

Mag-TD

active stimulation
Sham iTBSDEVICE

Mag-TD

Sham stimulation

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, 671014, China

RECRUITING

Related Publications (1)

  • 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: 40204331DERIVED

MeSH Terms

Conditions

SchizophreniaBody Weight

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Renrong Wu, M.D. Ph.D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renrong Wu, M.D. Ph.D

CONTACT

+8615874179855wurenrong@csu.edu.cn

Jing Huang, M.D. Ph.D

CONTACT

15874290980jinghuangserena@csu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial testing iTBS versus sham
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Department of Psychiatry, the Second Xiangya Hospital of Central South University.

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 24, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(2)