RecruitingNot ApplicableNCT05783063

iTBS for Increased Appetite Induced by Antipsychotics

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


Sponsor

Central South University

Enrollment

60 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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.

Exclusion Criteria9

  • 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;
  • Other abnormal examination results considered to be inappropriate for inclusion by researchers.

Interventions

DEVICEActive iTBS

Mag-TD

DEVICESham iTBS

Mag-TD


Locations(2)

Central South University

Changsha, Hunan, China

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China

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NCT05783063


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