NCT05783063Recruiting
iTBS for Increased Appetite Induced by Antipsychotics
Effects of Intermittent Theta Burst Stimulation (iTBS) on Increased Appetite Induced by Antipsychotics in Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Feb 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Central South University
- Diseases
- Schizophrenia
- NCT number
- NCT05783063
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Aug 2023 to the primary completion date, 1 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving regular MECT, or weight-loss therapy in the latest month;
Other illness
- 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;
Other
- Suicidal thoughts or behaviors;
- Alcohol or substance abuse;
- Pregnant or lactating women;
- Other contraindications of MRI;
- Other abnormal examination results considered to be inappropriate for inclusion by researchers.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| The Second People's Hospital of Dali Bai Autonomous Prefecture Coordinator of this site? Confirm its status | Dali | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.