ACTRN12623001019695招募中2 期
A Double-Blinded, 4-Arm, Covariate-Adjusted Adaptive Clinical Trial Evaluating the Efficacy of Novel Pharmacological Agents for the Treatment of Anorexia Nervosa in Individuals Aged 16 and Over
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
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 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) of equal to or greater than 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.
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 The Royal Australian and New Zealand College of Psychiatrists (RANZCP) Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
- •a.High refeeding risk;
- •b.Vital signs as follows:
- •i.Systolic BP < 80 mmHg;
- •ii.Postural BP drop > 20 mmHg systolic, > 10 mmHg diastolic;
- •iii.Heart rate < 40 or > 110;
- •iv.Postural tachycardia >20bpm
- •v.Temperature < 35.5°C.
- •c.ECG changes not overtly benign
- •d.Blood tests within the preceding 7 days showing:
- •i.Blood Glucose <3.0 mmol/L
- •ii.Serum sodium <130 mmol/L
- •iii.Serum magnesium < 0.6 mmol/L
- •iv.Serum potassium <3.0 mmol/L
- •v.Serum phosphate <0.7 mmol/L
- •vi.Glomerular filtration rate < 60ml/min (Cockroft-Gault)
- •vii.Albumin <27 g/L
- •viii.Liver Enzymes ALT > 3 x upper limit of normal
- •ix.Neutrophils <1.0x109/L
- •4.Participants who are pregnant or breastfeeding
- •5.Participants who are taking antipsychotic medication. Antipsychotics that are used as needed may be accepted at the clinical judgement of the investigator.
- •6.Taking equal to or greater than 4 psychotropic medications at the time of screening.
- •7.Diagnosed with Type I diabetes, hyperthyroidism, Crohn’s disease or other conditions that reduce weight
- •8.Other clinically significant cardiac, respiratory, renal, oncological or endocrine conditions, or evidence of medical instability, at the clinical judgement of the investigator.
- •9.Current substance use meeting DSM-5 criteria for severe substance use disorder.
- •10.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.
- •11.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).
- •12.Participants with severe and enduring anorexia, defined by an illness duration of at least 7 years.
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