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The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain

RecruitingNAAges 18 Years - 60 YearsAllSecond Xiangya Hospital of Central South Universi…
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In plain words

What the trial is, and whether it could suit you

Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain. Recently, research suggest that Accelerated dTMS (a-dTMS) which deliver more than one daily TMS session indicates greater efficacy than other TMS treatment. Symptom provocation is believed to improve the clinical responses to TMS. In this study, the investigators, firstly, evaluate the safety and effectiveness of a-dTMS for reducing antipsychotic-induced weight gain and secondly, to establish a predictive model of therapeutic response and to explore the underlying mechanisms of dTMS for reducing antipsychotic-induced weight gain, based on multimodal radiomics and metabolomics approaches.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged between 18-60. * Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). * Gaining body weight around 7% after intaking antipsychotics within 2 years. * Participants were on a stable medication regimen at the time of enrollment. ●Written informed consent was obtained from both the participants and their legally authorized guardians. Exclusion Criteria: * Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period. * Diagnosed with other mental diseases in accordance with DSM-V. * Comorbid with other severe physiological diseases. * Active suicidal ideation. * A history of alcohol or substance use disorder (or abuse). * Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI). * Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation. * Receipt of regular transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month. * Pregnant or lactating women
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What it tests

  • dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS
  • Sham stimulation
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Where

1 site
The Second Xiangya Hospital of Central South University
Changsha, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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