A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
dTMS
The Study of Improving Antipsychotic-induced Appetite by Deep Transcranial Magnetic Stimulation: The Effects of Improving Antipsychotic-induced Appetite by Single Session dTMS After Food Cue-induced Craving, A Randomized, Crossover and Sham-Controlled Trail
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Sep 2026
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 8, 2026
September 1, 2026
8 months
August 26, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Secondary Outcomes (4)
Visual Analogue Scale, VAS
Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
Changes of Stop-Signal mean reaction time (SSRT)
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Resting-state functional magnetic resonance imaging
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Task-state functional magnetic resonance imaging
Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
Study Arms (3)
Active dTMS after food cue induced craving (dTMS+FCC)
EXPERIMENTALParticipants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after food cue induced craving by watching the personalized video based on each participant's favorite food choices
Active dTMS after non food cue induced craving (dTMS+NON FCC)
ACTIVE COMPARATORParticipants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
Sham dTMS after non food cue induced craving (SHAM dTMS+NON FCC)
SHAM COMPARATORParticipants will receive single session of sham-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
Interventions
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.
The study will utilize an identical protocol using the H4 coil to administer a sham condition.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This study used a single-blind design, with participants blinded to treatment allocation. The device operator was not blinded due to differing parameter settings between active and sham stimulation, but was not involved in recruitment, clinical assessment, or data analysis. To maintain blinding integrity, participants were prohibited from discussing treatment-related sensations with the operator or among themselves. The sham procedure mimicked the initial scalp sensation of active stimulation to enhance blinding credibility.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders
Study Record Dates
First Submitted
August 26, 2026
First Posted
September 8, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 8, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share