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Schizophrenia SpectrumdTMSNCT07795554

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

A study testing dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS in people with Schizophrenia Spectrum and Schizophrenia, run by Second Xiangya Hospital of Central South University at 1 site in China.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
1 Sep 2026to 1 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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 transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month.
  • Pregnant or lactating women

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    KaHei Chan, +86-18890384723, heimradchan@foxmail.com

Other trials in China

About this study

Official title: The Effects of Improving Antipsychotic-induced Weight Gain by Accelerated dTMS After Food Cue-induced Craving, A Double-Blind, Randomized, Sham-Controlled Clinical Trial.

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.

Read the detailed description

The underlying causes of antipsychotic-induced weight gain are still unknown. Some research point out that it has something to do with metabolic disturbances and changes in appetite and food intake, acting food-craving-like behave which some points are similar to addiction. With fMRI study, it is reported having dysfunction between prefrontal and insula cortex of its cognitive regulation, interoceptive signals and reward control. dTMS, H coil in particular, simultaneously targets prefrontal and insula cortex, approved by FDA for Smoking Addiction recently. Previous study has been deconstrued that H coil could significantly improve weight gain than figure-eight Coils. Moreover, It is reckoned that TMS has state-dependent effects on brain circuitry, suspected that symptom provocation may be made it more susceptible to modulation which may improve response. Therefore, this study is to explore the efficacy of a-dTMS on antipsychotic-induced appetite, and use multimodal radiomics and metabolomics approaches to unveil the underlying mechanisms of dTMS for reducing antipsychotic-induced weight gain.

With regard to investigate this, we will be carried out a randomized, double-blind, sham-controlled clinical trial. 60 Patients with schizophrenia will be randomly treated with active a-dTMS or sham condition for 3 sections' interventions per day last for 10 days. The follow-ups are at baseline, the 12th day and the 42th day after the end of treatment. The main outcome measures include the change in body weight, BMI, TFEQ score, FCQ-S score, FCQ-T score and the resting and task-state EEG-fMRI imaging data.

Being tested
dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS, Sham stimulation
Keywords
Schizophrenia, Antipsychotic induced weight gain, dTMS
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dTMS of accelerated intermittent theta burst stimulation, ACC-iTBSDevice

    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 stimulationDevice

    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 groups in NCT07795554
Study groupRoleWhat they receive
a-dTMS stimulationExperimentalThe 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.
Receives: Device: dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS
Sham stimulationSham comparatorThe 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.
Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BMI

    Unit of measure: BMI in kg/m^2 (weight in kilograms, height in meters)

    Measured: Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42)

  2. Change in body weight

    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.

    Measured: Change in body weight between baseline and the end of the treatment (day 12) and follow-up (day 42)

Secondary outcomes (9)
  1. Change in abdominal and hip circumference

    The Change in abdominal and hip circumference absolute values (cm) will be measured at baseline and the end of the treatment (day 12) and follow-up (day 42) to evaluate weight-related treatment responses of dTMS.

    Measured: Change in abdominal and hip circumference between baseline and the end of the treatment (day 12) and follow-up (day 42)

  2. Change in Three Factor Eating Questionnaire (TFEQ)

    The Food Cravings Questionnaire-Trait (FCQ-T) is a self-reported measures which is a 39-item questionnaire that has nine subscales: intentions and plans to consume food, outcome expectancy of positive reinforcement, outcome expectancy of relief from negative states, anticipated lack of overeating control, preoccupation with food, physiological deficits and responses which may elicit craving, emotions experienced during food craving, external and internal cues that trigger cravings, and guilt.

    Measured: Change in TFEQ between baseline and the end of the treatment (day 12) and follow-up (day 42)

  3. Change in Food Cravings Questionnaire-Trait (FCQ-T)

    The change of food craving will be evaluated by Food Cravings Questionnaire-Trait (FCQ-T), a self-report multidimensional questionnaire composed of 39 items aimed to investigate food addiction and eating disorders. Total FCQ-T score will be used as a general measure of trait craving; individual FCQ-T scores related to the 9 measured craving dimensions could be useful in identifying and differentiating craving profiles between specific populations.

    Measured: Change in FCQ-T between baseline and the end of the treatment (day 12) and follow-up (day 42)

  4. Change in Food Craving Questionnaire State (FCQ-S)

    The Food Craving Questionnaire-State (FCQ-S) is a 15-item self-report measure to assess momentary, state-dependent food craving. The instrument consists of five multidimensional subscales: (1) intense desire to eat, (2) anticipation of positive reinforcement from eating, (3) anticipation of relief from negative states and feelings as a result of eating, (4) lack of control over eating, and (5) craving as a physiological state. Respondents rate each item on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Total scores are calculated by summing all 15 item responses, yielding a possible range of 15 to 75. Higher total scores indicate more intense current state food cravings.

    Measured: Change in FCQ-S between baseline and the end of the treatment (day 12) and follow-up (day 42)

  5. Change of Visual Analogue Scale, VAS

    The VAS is a simple, quick-to-administer, and sensitive instrument for detecting acute fluctuations in food craving, hunger, and related motivational states in response to food cue exposure. In the context of food cue reactivity, the VAS is administered immediately before and after presentation of food stimuli (e.g., pictorial food cues, actual food exposure, or virtual reality food environments) to capture acute changes in craving, hunger, appetite, and related motivational states. The VAS consists of a 100-mm horizontal line anchored at each end by verbal descriptors representing the extremes of the construct being measured, typically ranging from 0 ("not at all" or "no desire at all") to 100 ("extremely" or "very strong desire").The score is determined by measuring the distance in millimeters from the left anchor to the respondent's mark, yielding a possible range of 0 to 100, with higher scores indicating greater intensity of the measured construct.

    Measured: Change in VAS between each food cue induced craving and food cue reactivity before and after

  6. Change in parameters of the Stop Signal Task, SST

    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 primary outcome measure derived from the SST is the stop-signal reaction time (SSRT) , which is an estimated measure of the speed of the inhibitory process. The SSRT is calculated by subtracting the mean or median stop-signal delay (SSD) from the mean or median reaction time on go trials. Higher SSRT values indicate longer inhibition latency and thus poorer inhibitory control, whereas lower SSRT values indicate faster inhibition and better inhibitory control.

    Measured: Change in parameters of SST between baseline and the end of the treatment (day 12) and follow-up (day 42)

  7. Change in parameters of the Go/No-Go Task (GNG)

    The Go/No-Go Task (GNG) is a computerized behavioral paradigm that measures response inhibition-specifically, the ability to withhold a prepotent motor response to a frequently occurring stimulus when an infrequent, conflicting stimulus occurs.The GNG task comprises two types of trials presented in random order: Go trials (typically 70-80% of all trials) and No-Go trials (typically 20-30% of all trials).The most critical outcome derived from the GNG task is the No-Go error rate, calculated as the number of incorrect responses on No-Go trials divided by the total number of No-Go trials. Higher No-Go error rates indicate poorer inhibitory control.

    Measured: Change in parameters of GNG between baseline and the end of the treatment (day 12) and follow-up (day 42)

  8. Change in Blood laboratory parameters

    About 20ml blood samples were collected intravenously to test blood routine, liver and kidney function, electrolytes and other routine tests. Changes in lipid metabolism will be evaluated by Cholesterol (mg/dL), Triglycerides (mg/dL), High-Density Lipoprotein Cholesterol (mg/dL), Low-Density Lipoprotein Cholesterol (mg/dL), Fasting Blood Glucose (mmol/L).

    Measured: Change in Blood laboratory parameters between baseline and the end of the treatment (day 12) and follow-up (day 42)

  9. Change in correlation of fMRI and EEG functional connectivity

    Examines how brain connectivity patterns measured by fMRI (blood-flow activity) relate to connectivity patterns measured by EEG (electrical activity).

    Measured: Change in correlation of fMRI and EEG functional connectivity between baseline and the end of the treatment (day 12) and follow-up (day 42)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
60 participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795554
Sponsor's protocol ID
LYEC2026-0195-Study B
Other IDs
82571770
Acronym
dTMS
Status last verified
Sep 2026
First submitted
26 Aug 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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