【ChiCTR2400089293】Effect of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor on reducing atypical antipsychotics-induced weight gain in schizophrenia spectrum disorder – A Randomized Controlled Trial

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基本信息

登记号

ChiCTR2400089293

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2024-09-05

临床申请受理号

靶点

适应症

Schizophrenia spectrum disorder

试验通俗题目

Effect of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor on reducing atypical antipsychotics-induced weight gain in schizophrenia spectrum disorder – A Randomized Controlled Trial

试验专业题目

Effect of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor on reducing atypical antipsychotics-induced weight gain in schizophrenia spectrum disorder – A Randomized Controlled Trial

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

The subjects will be randomly allocated to the SGLT2 inhibitor group or the placebo group by a block randomization procedure with 1:1 group allocation. Allocation concealment will be adopted to prevent selection bias. The randomization sequence will be electronically generated, and conducted independently of the study psychiatrist in separate facility by helper.

盲法

Both the assessor and the subjects will be blinded to the procedure. All subjects will not be informed of the group allocation during the study, and they will be assessed by the study psychiatrist who is blinded to the group allocation. Both placebo and empagliflozin will be matched in size and appearance. Unblinding will be performed whenever needed for safety reasons.

试验项目经费来源

Not applicable; there is no funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2023-11-17

试验终止时间

2024-09-30

是否属于一致性

入选标准

1) Who are 18-64 years old; 2) 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; 3) 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; 4) 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); 5) Who are able to understand spoken instructions in Cantonese and are able to read traditional Chinese; 6) Being clinically stable as assessed by their treating psychiatrist and having a Clinical Global Impressions scale severity rating (CGI-S) ≤4 (moderately ill) 7) Who are able to give informed consent.；

排除标准

1) 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); 2) 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). 3) Who had used any medication for weight loss within the preceding month prior to study entry; 4) Who are having treatment with oral corticosteroids; 5) Suffering from recurrent genitourinary infection, defined as ≥2 infections in past six months or ≥3 infections in the past year; 6) Who are in pregnancy or lactation within recent 3 years.；

研究者信息

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试验机构

Tai Po Hospital

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