About this trial
Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain. dTMS which is a safe and non-invasive physical treatment indicates greater efficacy than other transcranial magnetic stimulation (TMS) by some research. Apart from that, symptom provocation is believed to improve the clinical responses to TMS. In this study, the investigators, firstly, evaluate the safety and effectiveness of dTMS for reducing antipsychotic-induced weight gain and secondly, unveil whether symptom provocation can affect the clinical responses to TMS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active
DeviceThe study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS). The stimulation intensity is set at 90% 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.
Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham
DeviceThe study will utilize an identical protocol using the H4 coil to administer a sham condition.
Treatment groups
Trial outcomes
Primary outcomes
Food Craving Questionnaire State, FCQ-S
The assessment of food cravings. The FCQs consists of 15 items to be scored on a 5-point scale ranging from strongly disagree to strongly agree. Its original form comprises five subscales measuring current food craving in relation to (1) an intense desire to eat, (2) anticipation of positive reinforcement, (3) relief from negative states, (4) lack of control over eating, and (5) hunger.
Secondary outcomes
Visual Analogue Scale, VAS
The Visual Analogue Scales required the subjects to rate hunger, satiety, thirst, fullness and emptiness on a 0-100 mm scale. The Visual Analogue Scales of Craving was assessed two times: before the provocation procedure, and after the provocation procedure
Changes of Stop-Signal mean reaction time (SSRT)
The SST aims to access cognitive behavioral inhibition control. The study employed a task that comprised randomly interleaved NoGo and Stop-Signal trials to examine both types of inhibition. The study measured six behavioral parameters of interest: namely Mean Go reaction time (GoRT), Stop-Signal mean reaction time (SSRT), Stop-Signal delay (SSD), Target accuracy, Go trial accuracy, and NoGo Accuracy. The SST main outcome is the changes of Stop-Signal mean reaction time (SSRT)
Resting-state functional magnetic resonance imaging
All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
Task-state functional magnetic resonance imaging
Measure of the immediate activation (blood-oxygen-level-dependent change) in the brain regions related to appetite neural circuits under food cue reactivity task
Sponsors and contacts
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