ISRCTN61129760已完成3 期
iraglutide and the management of overweight and obesity in people with schizophrenia: a pilot study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18-75 years old
- •2. Clinical diagnosis of schizophrenia or schizoaffective disorder (defined by ICD-10 codes F20 and F25) or first episode psychosis using case note review. There is no limit on the duration of illness for those with schizophrenia or schizoaffective disorder but first episode psychosis is defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription
- •3. Treatment with an antipsychotic, with a minimum duration of 1 month prior to entry in to the trial. No restriction is placed on the class or generation of antipsychotic
- •4. Ability to give written informed consent
- •5. Ability and willingness to take liraglutide or placebo
- •6. Ability to speak and read English
- •7. Body mass index = 30 kg/m² (obese), or = 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes), hypertension, dyslipidaemia or obstructive sleep apnoea
排除标准
- •1. Physical illnesses that could seriously reduce their life expectancy or ability to participate in the trial
- •2. A co-existing physical health problem that would, in the opinion of the principal investigator, independently impact on metabolic measures or weight, e.g. Cushing’s syndrome.
- •3. Severe renal or hepatic impairment
- •4. Inflammatory bowel disease
- •5. Contraindications to Saxenda®: Hypersensitivity to liraglutide or to any of the excipients
- •6. Use of other pharmacological products for weight management
- •7. Mental illnesses that could seriously reduce their ability to participant in the trial, including significant suicidality. Every patient in contact with the Southern Health Trust has a risk assessment which is recorded on the electronic patient record (RIO). If the risk assessment states that they are at High” risk of harm to themselves, we would exclude the patient from the study. In addition, prior to recruitment, we will approach any potential participant’s care coordinators to verify the currently recorded risk, to ensure that the risk status has not changed.
- •8. Current pregnancy or a desire to become pregnant. Mothers who are less than 6 months post-partum or breastfeeding will also be excluded. Women who become pregnant during the trial will be advised to stop the study medication and will be withdrawn from the trial
- •9. Significant alcohol or substance misuse which, in the opinion of the principal investigator, would limit the patient’s ability to participate in the trial.
- •10. A diagnosis or tentative diagnosis of psychotic depression or mania.
- •11. A primary diagnosis of learning disability.
- •12. Lack of capacity. Those who lose capacity any time during the study will not be eligible to continue and will be withdrawn from the study immediately with no further study procedures carried out.
- •13. Cognitive impairment which would impair participants ability to self-administer trial medication
- •14. History of type 1 diabetes
研究者
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