Prevalence of metabolic syndrome and its risk factors in patients receiving Clozapine therapy for schizophrenia- A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- proportion of patients with Schizophrenia on Clozapine showing increased risk for metabolic syndrome
研究概览
简要总结
There is a high prevalence of metabolic syndrome in our country. In a vulnerable population such as psychotic patients, it becomes especially important to monitor MetS as atypical antipsychotics are well known to produce metabolic disturbances. This would enable us to develop strategies and standard operating procedures for monitoring these patients to prevent these disorders and improve treatment adherence.
In this study we aim to identify the prevalence of Metabolic Syndrome in patients undergoing Clozapine therapy for patients of Schizophrenia.
Hypothesis- Clozapine therapy leads to increased risk of acquiring metabolic syndrome in patients with schizophrenia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All genders aged between 18 years to 65 years.
- •All patients with Schizophrenia diagnosed as per International Classification of disease 10 (ICD-10).
- •Patients prescribed Clozapine.
- •Medically stable patients.
排除标准
- •Unstable patients i.e. patients with violence, suicide risk, and risk of harm to self/others.
- •Patients with diagnosable intellectual disability.
- •Pregnant or lactating patients.
- •Medically unstable patients.
- •Severely physical disability or locomotive disability.
- •History of substance dependence other than tea or coffee.
- •History of significant weight loss in the past month.
- •Patients on metabolism-friendly medication (Such as Aripiprazole, Brexpiprazole, Lurasidone, Topiramate etc).
结局指标
主要结局
proportion of patients with Schizophrenia on Clozapine showing increased risk for metabolic syndrome
时间窗: 6 months
次要结局
- To assess the risk for developing diabetes(6 months)
- To assess the improvement in symptoms(6 months)
- To assess clozapine-related adverse drug reactions and their frequency in the study population.(6 months)
- To check for adherence to Clozapine therapy in patients with schizophrenia(6 months)
研究者
Dr Renu Thakur
All India Institute of Medical Sciences, Raipur