The Purpose of the Study is to Evaluate the Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain

Sponsor
Second Xiangya Hospital of Central South University
Study ID
NCT07795554
Status
Not Yet Recruiting

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Conditions

  • Antipsychotic Induced Weight Gain
  • Schizophrenia
  • Schizophrenia Spectrum

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS — DEVICE
    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 — DEVICE
    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 Details

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, we, 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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
May 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: a-dTMS stimulation
    The patients in a-dTMS stimulation group will receive accelerated intermittent theta burst stimulation (ACC-iTBS) stimulation for 10 consecutive days and 3 times per day. There will have at least 50 minutes interval between each intervention. Participants will be undertaking symptom provocation named food cue induced craving before each stimulation.
  • Sham Comparator: Sham stimulation
    The participants in sham stimulation will receive sham coil stimulation for 10 consecutive days and 3 times per day. There will have at least 50 minutes interval between each intervention. Participants will be undertaking symptom provocation named food cue induced craving before each stimulation.

Primary Outcome Measure

Change in BMI [ Time Frame: Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42) ]

Central Contacts

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