ACTRN12624000368538尚未招募2 期
Evaluating the Effectiveness of Sodium Butyrate for Treatment of Anorexia Nervosa in Individuals Aged 16 and Over - An Open-Label Proof of Concept Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Diagnosis of anorexia nervosa (restrictive or binge-eating/purging subtype), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
- •2.16 years or older in age.
- •3.Baseline body mass index (BMI) greater than or equal to 14
- •4.Demonstrated capacity to give informed consent.
- •5.No initiation of therapies targeting AN within the 4 weeks prior to screening. This includes pharmacological and psychological therapies.
- •6.No increase or initiation of medications with appetite suppressing and/or weight loss effects within the 4 weeks prior to screening.
- •7.Engagement with a GP at the time of enrolment and over the course of trial participation.
- •8.Consent for the research team to communicate with the participant’s clinical treatment team in regard to a) Their progress through the trial and b) Communicate clinical deterioration and risks to allow facilitation of appropriate management, where clinically-indicated.
- •9.Eligibility for Medicare
排除标准
- •1.Inability to provide informed consent.
- •2.Hospitalisation within the 2-months prior to screening for the purpose of managing risk of refeeding or treatment of other medical instability that has a causal link with AN.
- •3.Physical parameters meeting Criteria for Medical Ward Admission as per the RANZCP Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
- •a.High refeeding risk;
- •b.Vital signs as follows:
- •i.Systolic BP less than 80 mmHg;
- •ii.Postural BP drop greater than 20 mmHg systolic, greater than 10 mmHg diastolic;
- •iii.Heart rate less than 40 or greater than 110;
- •iv.Postural tachycardia greater than 20bpm
- •v.Temperature less than 35.5°C.
- •c.ECG changes not overtly benign
- •d.Blood tests within the preceding 7 days showing:
- •i.Blood Glucose less than 3.0 mmol/L
- •ii.Serum sodium less than 130 mmol/L
- •iii.Serum magnesium less than 0.6 mmol/L
- •iv.Serum potassium less than 3.0 mmol/L
- •v.Serum phosphate less than 0.7 mmol/L
- •vi.Glomerular filtration rate less than 60ml/min (Cockroft-Gault)
- •vii.Albumin less than 27 g/L
- •viii.Liver Enzymes ALT greater than 3 x upper limit of normal
- •ix.Neutrophils less than 1.0x109/L
- •e.GCS less than 15
- •4.Participants who are pregnant or breastfeeding
- •5.Taking more than 4 psychotropic medications at the time of screening.
- •6.Diagnosed with Type I diabetes, hyperthyroidism, Crohn’s disease or other conditions that reduce weight
- •7.Other clinically significant cardiac, respiratory, renal, oncological or endocrine conditions, or evidence of medical instability, at the clinical judgement of the investigator.
- •8.Current substance use meeting DSM-5 criteria for severe substance use disorder.
- •9.Diagnosis of any other mental disorder that is the participant’s primary diagnosis or main mental health syndrome of concern at the time of screening, which may significantly affect psychiatric status and assessed as likely to impact trial participation, at the clinical judgement of the investigator.
- •10.Use of any investigational procedure (e.g., clinical trial) within 30 days prior to randomisation. In case of exposure to an investigational medicinal product, the investigator must ensure that it is adequately washed out prior to randomisation (at least 30 days or 5 half-lives of the investigational medicinal product, whatever is longer).
- •11.Participants with severe and enduring anorexia, defined by an illness duration of at least 7 years.
研究者
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