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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More Second Xiangya Hospital of Central South University trials in China

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