ACTRN12619001559101尚未招募4 期
A double-blind, randomised placebo-controlled clinical trial using metformin as an adjunct to a healthy lifestyle behavioural intervention to improve cardiometabolic outcomes and affective syndromes in youth with clinically diagnosed mood and psychotic syndromes
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 266
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
- 16 Years 至 25 Years（—）
- 性别
- All
入选标准
- •Aged between 16 and 25
- •- A current diagnosis of a mood or psychotic syndrome (including anxiety, depression, bipolar disorder and psychosis) according to the Diagnostic and Statistical Manual of Mental Disorders, version V (DSM-IV) criteria using the Structured Clinical Interview for DSM-5 (SCID)
- •- Independent written informed consent given by the subject
- •- BMI greater than 25 (overweight or obese)
- •AND AT LEAST ONE OF THE FOLLOWING
- •- HOMA-2IR value greater or equal to 1.5
- •- Currently on and/or commencing psychotropic medication (antipsychotics, antidepressants, mood stabilizers) under psychiatric supervision
- •- Mental illness has reached Stage 2- Discrete Disorders” in the Clinical staging model framework for mood and psychotic syndromes
排除标准
- •Those not competent to provide informed consent
- •Lifetime use of metformin or any other glucose lowering medication
- •Lifetime diagnosis of T1 or T2DM diabetes (gestational diabetes accepted)
- •Intellectual disability (at investigator’s discretion);
- •Major neurological disorder, medical illness which impacts on cognition, and/or a history of sustained head injury;
- •Not fluent in English
- •Significant alcohol or other substance misuse or substance dependence;
- •An acute psychotic or manic episode that impairs the individual’s ability to give informed consent and/or requires acute clinical treatment
- •Acute suicidal behaviour (score of 6 on Comprehensive Assessment of At-Risk Mental States (CAARMS) item 7.3)
- •Contraindications to metformin including acute alcohol intoxication or severe infection.
- •Current pregnancy, lactation, or plans to become pregnant
研究者
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