Using iTBS to Manage Increased Appetite from Antipsychotics in Schizophrenia

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

This study is testing if a new brain stimulation technique can help people with schizophrenia manage increased appetite caused by their antipsychotic medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Central South University (other)
• Locations: 2 sites (Changsha, Hunan and 1 other locations)
• Trial ID: NCT05783063 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-40 with a diagnosis of schizophrenia who have experienced significant weight gain or have a BMI of 25 or higher due to antipsychotic treatment.

Not a fit: Patients with severe mental illnesses other than schizophrenia, significant cognitive impairments, or those with abnormal brain structures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help manage appetite-related side effects of antipsychotic medications, improving the overall health and quality of life for patients with schizophrenia.

How similar studies have performed: While conventional high-frequency rTMS has shown effectiveness in treating obesity, studies specifically using iTBS in schizophrenia patients are rare, making this approach relatively novel.

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.

Where this trial is running

Changsha, Hunan and 1 other locations

• Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali, Yunnan, China (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

Conditions: Schizophrenia, appetite, weight, antipsychotics, iTBS