The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain (dTMS)
1 de septiembre de 2026 actualizado por: Ping Shao, Second Xiangya Hospital of Central South University
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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ping Shao
- Número de teléfono: +86-13755112445
- Correo electrónico: shp97jw@163.com
Copia de seguridad de contactos de estudio
- Nombre: Renrong Wu
- Número de teléfono: +86-15874179855
- Correo electrónico: wurenrong@csu.edu.cn
Ubicaciones de estudio
-
-
Hunan
-
Changsha, Hunan, Porcelana, 410011
- The Second Xiangya Hospital of Central South University
-
Contacto:
- KaHei Chan
- Número de teléfono: +86-18890384723
- Correo electrónico: heimradchan@foxmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month.
- Pregnant or lactating women
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: a-dTMS stimulation
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.
|
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.
|
|
Comparador falso: Sham stimulation
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in BMI
Periodo de tiempo: Change in BMI between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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
Periodo de tiempo: Change in body weight between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Three Factor Eating Questionnaire (TFEQ)
Periodo de tiempo: Change in TFEQ between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
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)
Periodo de tiempo: Change in FCQ-T between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
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)
Periodo de tiempo: Change in FCQ-S between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
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
Periodo de tiempo: Change in VAS between each food cue induced craving and food cue reactivity before and after
|
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.
|
Change in VAS between each food cue induced craving and food cue reactivity before and after
|
|
Change in parameters of the Stop Signal Task, SST
Periodo de tiempo: Change in parameters of SST between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
Change in parameters of SST between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
|
Change in parameters of the Go/No-Go Task (GNG)
Periodo de tiempo: Change in parameters of GNG between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
Change in parameters of GNG between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
|
Change in Blood laboratory parameters
Periodo de tiempo: Change in Blood laboratory parameters between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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).
|
Change in Blood laboratory parameters between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
|
Change in correlation of fMRI and EEG functional connectivity
Periodo de tiempo: Change in correlation of fMRI and EEG functional connectivity between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
Examines how brain connectivity patterns measured by fMRI (blood-flow activity) relate to connectivity patterns measured by EEG (electrical activity).
|
Change in correlation of fMRI and EEG functional connectivity between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
|
Change in abdominal and hip circumference
Periodo de tiempo: Change in abdominal and hip circumference between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
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.
|
Change in abdominal and hip circumference between baseline and the end of the treatment (day 12) and follow-up (day 42)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
31 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LYEC2026-0195-Study B
- 82571770 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .