ChiCTR2400089293已完成2 期
Effect of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor on reducing atypical antipsychotics-induced weight gain in schizophrenia spectrum disorder – A Randomized Controlled Trial
Not applicable; there is no funding5 个研究点 分布在 1 个国家开始时间: 2023年11月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 5
- 主要终点
- Body weight (kg)
研究概览
简要总结
The primary objective of the study is to evaluate the effect of the combination of SGLT2 inhibitor and lifestyle intervention on weight in patients suffering from schizophrenia spectrum disorder on atypical antipsychotics, compared to the combination of placebo and lifestyle intervention.
The secondary objectives of the study include: (i) To evaluate the effect of SGLT2 inhibitor on improving the metabolic traits in patients with schizophrenia spectrum disorder who is taking atypical antipsychotics, compared to the placebo group receiving the same lifestyle intervention. (ii) To compare the safety profile and incidence of adverse events between SGLT2 inhibitor and placebo in patients suffering from schizophrenia spectrum disorder on atypical antipsychotics.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Who are 18-64 years old;
- •Who met criteria for schizophrenia spectrum and other psychotic disorders on Chinese-bilingual Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I, patient version (SCID-I) except for substance/medication-induced psychotic disorder, psychotic disorder due to another medical condition, catatonia associated with another mental disorder, catatonic disorder due to another medical condition, and unspecified catatonia;
- •Who are receiving at least one of the targeted atypical antipsychotics -- clozapine, olanzapine, quetiapine, risperidone or paliperidone, for 6 months with its dosage and concomitant psychiatric medications not changed over the past 1 month prior to study entry;
- •Who are Asians with Body Mass Index (BMI) ≥ 23 kg/m2 (Classified as overweight or obese according to World Health Organization (WHO)’s classification for Asia-Pacific);
- •Who are able to understand spoken instructions in Cantonese and are able to read traditional Chinese;
- •Being clinically stable as assessed by their treating psychiatrist and having a Clinical Global Impressions scale severity rating (CGI-S) ≤4 (moderately ill)
- •Who are able to give informed consent.
排除标准
- •Who had received a psychiatric diagnosis other than schizophrenia spectrum disorder as confirmed by SCID-I, had learning disability or had any active substance abuse or dependence for the past six months (except for nicotine);
- •With evidence of active liver, thyroid or renal dysfunction, cardiovascular disease, uncontrolled hypertension, diabetes mellitus or malignancy, defined as:
- •i. Liver dysfunction: liver transaminases >3 times upper normal limit;
- •ii. Renal dysfunction: estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2;
- •iii. Cardiovascular disease: decompensated heart failure (New York Heart Association (NYHA) class III or IV), unstable angina pectoris and/ or myocardial infarction within the last 12 months;
- •iv. Uncontrolled hypertension: systolic blood pressure >180mmHg or diastolic blood pressure >100 mmHg;
- •v. Diabetes mellitus: HbA1c >6.4% (conventional unit).
- •Who had used any medication for weight loss within the preceding month prior to study entry;
- •Who are having treatment with oral corticosteroids;
- •Suffering from recurrent genitourinary infection, defined as ≥2 infections in past six months or ≥3 infections in the past year;
- •Who are in pregnancy or lactation within recent 3 years.
研究组 & 干预措施
SGLT2 inhibitor group
Placebo group
结局指标
主要结局
Body weight (kg)
Body Mass Index (BMI)(kg/m2)
次要结局
- Waist circumference (cm)
- Low-density lipoprotein (LDL) (mmol/L)
- High-density lipoprotein (HDL) (mmol/L)
- Total triglycerides (TG) (mmol/L)
- Blood pressure (mmHg)
- HbA1c (mmol/mol)
- Fasting glucose (mmol/L)
- Incidence of adverse events
研究者
研究点 (5)
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