NCT05783063 iTBS for Increased Appetite Induced by Antipsychotics
| NCT ID | NCT05783063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central South University |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-08-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Renrong Wu, M.D. Ph.D
PRINCIPAL INVESTIGATOR
Department of Psychiatry, The Second Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT05783063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05783063 currently recruiting?
Yes, NCT05783063 is actively recruiting participants. Contact the research team at wurenrong@csu.edu.cn for enrollment information.
Where is the NCT05783063 trial being conducted?
This trial is being conducted at Changsha, China, Dali, China.
Who is sponsoring the NCT05783063 clinical trial?
NCT05783063 is sponsored by Central South University. The principal investigator is Renrong Wu, M.D. Ph.D at Department of Psychiatry, The Second Xiangya Hospital of Central South University. The trial plans to enroll 60 participants.
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