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

NCT07795554 | Not Yet Recruiting DMC

• 2 other identifiers: LYEC2026-0195-Study B82571770
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia Spectrum; Schizophrenia; Antipsychotic Induced Weight Gain

Keywords

Schizophrenia; Antipsychotic induced weight gain; dTMS

Outcome Measures

Primary Outcomes (2)

• Change in BMI

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

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

• 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.

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

Secondary Outcomes (9)

• Change in abdominal and hip circumference

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

• Change in Three Factor Eating Questionnaire (TFEQ)

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

• Change in Food Cravings Questionnaire-Trait (FCQ-T)

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

• Change in Food Craving Questionnaire State (FCQ-S)

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

• Change of Visual Analogue Scale, VAS

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

Study Arms (2)

a-dTMS stimulation

EXPERIMENTAL

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.

Device: dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation

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.

a-dTMS stimulation

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.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

PING SHAO

CONTACT

+86-13755112445; shp97jw@163.com

Renrong Wu

CONTACT

+86-15874179855; wurenrong@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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

Model Details: 60 participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)