ACTRN12617001547336招募中4 期
The efficacy of Metformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia or schizoaffective disorder newly commenced on clozapine
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •1.Aged between 18 and 64 years (inclusive)
- •2.Fulfil the DSM-IV criteria practice for schizophrenia or schizoaffective disorder, based on the Diagnostic Interview for Psychosis (DIP)
- •3.Have received oral clozapine for a period of no more than 2 weeks
- •4.Agree to participate, have capacity to consent and are able to follow the study instructions and procedures
- •5.Fasting Blood Glucose Level less than or equal to 5.6 mmols (confirmed within the previous two weeks of commencing clozapine)
- •6.BMI greater than or equal to 18 and less than or equal to 40
排除标准
- •1.Known allergies to Metformin or any part of the formulation of the investigational product
- •2.Obesity induced by other endocrinologic disorder (e.g Cushing Syndrome, untreated
- •Hypothyroidism)
- •3.Current use of any weight-lowering therapy including: pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine (either by prescription or as part of a clinical trial)
- •4.Diagnosis of Type 1 or Type 2 Diabetes mellitus or already on metformin
- •5.Participants treated with corticosteroids or other hormone therapy (except oestrogens or thyroxine) for greater than 10 days
- •6.Chronic kidney disease (eGFR<60mL/min)
- •7.Previous surgical treatment of obesity
- •8.BMI less than or equal to 18 or BMI greater than or equal to 40
- •9.Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for trial participation
- •10.People who are unable to understand or communicate in English
研究者
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