A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia

NCT07805980 · tracked via the Priya Life Science China tracker

Sponsor

Second Xiangya Hospital of Central South University

Phase

Not applicable

Started

2026-09-01

Last updated

2026-09-08

Condition(s) studied

SchizophreniaAntipsychotic Induced Weight Gain

Investigational drug(s) / intervention(s)

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - ActiveDeep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham

Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active: The 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: The study will utilize an identical protocol using the H4 coil to administer a sham condition.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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 repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month * Pregnant or lactating women

Primary outcome measure(s)

Food Craving Questionnaire State, FCQ-S — Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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.

Trial sites (1)

Facility	City	Region	Status
The Second Xiangya Hospital of Central South University	Changsha	Hunan

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Official registry record

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.

View NCT07805980 on ClinicalTrials.gov ↗ ← All trials in China