iTBS for Increased Appetite Induced by Antipsychotics
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Active iTBS, Sham iTBS.
- Кому может быть актуально
- Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of Intermittent Theta Burst Stimulation (iTBS) on Increased Appetite Induced by Antipsychotics in Patients With Schizophrenia
Обзор
Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Conventional high-frequency rTMS have been used to treat people with obesity and showed certain effectiveness. However, studies involving schizophrenia patients and intermittent theta burst (iTBS) mode are rarely seen. The goal of this clinical trial is to evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia.
Подробное описание
The study will evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks after intervention. 60 schizophrenia patients will be randomized to receive active or sham interventions administered to the left dorsolateral prefrontal cortex. The experimental group will be applied to active iTBS rTMS involving 600 pulses (3 minutes), 5x daily at 60 minutes intervals for 5 days. Changes in appetite from baseline to the end of the study will be measured by Three Factor Eating Questionnaire (TFEQ), Food Cravings Questionnaire-Trait (FCQ-T), Food Cravings Questionnaire-State (FCQ-S) and Visual Analogue Scale (VAS). Clinical symptoms and mood status will be assessed by Positive and Negative Symptom Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and Clinical Global Impression (CGI). Improvement of cognition could be measured by Delay Discounting Task (DDT), Stop-signal task (SST) and MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB). Changes of appetite related Indicators of glycolipid metabolism and neuroregulatory factor, along with microflora before and after intervention will be recorded by collecting blood and feces specimens. The adverse effect will be evaluated by Treatment Emergent Symptom Scale (TESS) and Adverse Event Record Form (AERF). Task-based magnetic resonance imaging (MRI) and arterial spin labeling (ASL) will be used to measure changes of brain activity associated with food stimuli and cerebral blood flow(CBF) before and after treatment.
Вмешательства
- Устройство Active iTBS
Mag-TD - Устройство Sham iTBS
Mag-TD
Первичные конечные точки
- Changes in body mass index (BMI) [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
Вторичные конечные точки (12)
- Changes in Positive and Negative Symptom Scale (PANSS) [Срок оценки: Baseline and 4 weeks post-treatment]
- Changes in Calgary Depression Scale for Schizophrenia (CDSS) [Срок оценки: Baseline and 4 weeks post-treatment]
- Changes in the Clinical Global Impressions (CGI) [Срок оценки: Baseline and 4 weeks post-treatment]
- Changes in brain perfusion. [Срок оценки: Baseline, after 5 treatment days and 4 weeks post-treatment]
- Changes in brain function. [Срок оценки: Baseline, after 5 treatment days and 4 weeks post-treatment]
- Changes in MCCB [Срок оценки: Baseline and 4 weeks post-treatment]
- Changes in SST. [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
- Changes in DDT. [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
- Changes in the Three-factor Eating Questionnaire (TFEQ) [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
- Changes in the Food Cravings Questionnaire-Trait (FCQ-T) [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
- Changes in the Food Cravings Questionnaire-State (FCQ-S) [Срок оценки: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment]
- Changes in the visual analogue scale (VAS) [Срок оценки: Everyday from baseline to 4 weeks after treatment]
Критерии участия
Критерии включения
- Age between 18-40 years old;
- Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);
- BMI ≥ 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;
- Not receiving TMS therapy in the past month;
- Using no more than two antipsychotic medications (including olanzapine, haloperidol, amisulpride, asenapine, risperidone, paliperidone, clozapine, quetiapine, iloperidone, chlorpromazine, sertindole, zotepine), not using antidepressants, mood stabilizers and other drugs, but allowing short-term use of benzodiazepines, benzhexol and propranolol;
- Signing written informed consents voluntarily.
Критерии исключения
- Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;
- Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;
- Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;
- Suicidal thoughts or behaviors;
- Alcohol or substance abuse;
- Pregnant or lactating women;
- Other contraindications of MRI;
- Receiving regular MECT, or weight-loss therapy in the latest month;
- Other abnormal examination results considered to be inappropriate for inclusion by researchers.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 2 центра
- Central South University — Чанша
- The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali
Публикации
- Qin Y, Yang J, Xu B, Yang J, Chen H, Zou T, Teng Z, Liu J, Zhang T, Su Y, Wu R, Dong Z, Yang C, Huang J. Effects of intermittent theta burst stimulation (iTBS) on appetite change and body weight in inpatients with schizophrenia in China: study protocol for a randomised controlled trial. BMJ Open. 2025 Apr 8;15(4):e090932. doi: 10.1136/bmjopen-2024-090932. PMID 40204331
Идентификаторы
NCT: NCT05783063 · WU20221015