Second Xiangya Hospital of Central South University
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-04
Condition(s) studied
Schizophrenia SpectrumSchizophreniaAntipsychotic Induced Weight Gain
Investigational drug(s) / intervention(s)
dTMS of accelerated intermittent theta burst stimulation, ACC-iTBSSham stimulation
dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS: The intensity of the stimulator is set at 80% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
Sham stimulation: The same procedure will be performed in sham coil induced acoustic and scalp sensations similar to those induced by the active coil, but without electromagnetic penetration into the brain and without neural activation.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change in BMI — Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42) Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters)
Change in body weight — Change in body weight between baseline and the end of the treatment (day 12) and follow-up (day 42) Change in body weight (kg) from baseline to Day 12 (end of treatment) and to Day 42 (follow-up), to evaluate the effectiveness of dTMS in reducing antipsychotic-induced weight gain.
Trial sites (1)
Facility
City
Region
Status
The Second Xiangya Hospital of Central South University
Changsha
Hunan
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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