Using iTBS to Manage Increased Appetite from Antipsychotics in Schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of intermittent theta burst stimulation (iTBS) in reducing increased appetite caused by antipsychotic medications in patients with schizophrenia. A total of 60 participants will be randomized to receive either active or sham iTBS treatments, administered to the left dorsolateral prefrontal cortex over five days. The study will measure changes in appetite and clinical symptoms using various questionnaires and scales, alongside assessments of cognitive function and metabolic indicators. Blood and fecal samples will be collected to analyze changes in neuroregulatory factors and microflora.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second People's Hospital of Dali Bai Autonomous Prefecture
  Dali, Yunnan, China Recruiting
• Central South University
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Principal investigator: Renrong Wu, M.D. Ph.D — Department of Psychiatry, The Second Xiangya Hospital of Central South University
• Study coordinator: Renrong Wu, M.D. Ph.D
• Email: wurenrong@csu.edu.cn
• Phone: +8615874179855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.