NCT06687993尚未招募2 期
Acetylcholinesterase Inhibitor Treatment in Anorexia Nervosa: a Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
Centre Hospitalier St Anne0 个研究点目标入组 147 人开始时间: 2024年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 147
- 主要终点
- Effect on Body Mass Index in adult women suffering from anorexia nervosa
研究概览
简要总结
The goal of this clinical trial is to learn if the daily take of donepezil can treat adult patient suffering from anorexia nervosa. The main question it aims to answer is : do daily donepezil intake permit weight gain and reduction of food restriction rituals ? The treatment is a capsule comprising a drug limiting the degradation of a neurotransmitter called acetylcholine. This treatment has long been used to treat certain cognitive disorders. Researchers will compare two drug dosage and a look-alike capsule that contains no drug to see if the dose has an impact on the effect. Participants will take one capsule per day for three months will have regular hospital visits for cognitive and metabolic tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design. Comparative analyzes will be carried out blindly
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of the 3 DSM-V criteria for Anorexia Nervosa
- •Restrictive subtype of Anorexia Nervosa according to DSM-5
- •Body Mass Index between 15 and 18.5 kg/m²
- •Aged 18 to 65 years
- •Resting heart rate > or = 40 bpm
- •Use of a highly effective contraceptive method
- •Affiliation or entitlement to a Health Insurance scheme
- •Prior free, informed, and written consent
排除标准
- •Presence of one or more somatic criteria for hospitalization according to french HAS 2010 guidelines
- •Past diagnosis of anorexia nervosa with binge-eating/purging type
- •Past diagnosis of bulimia nervosa
- •Past diagnosis of binge-eating disorder
- •Associated diagnosis of schizophrenia and/or persistent delusional disorder and/or bipolar disorder
- •History of asthma or obstructive bronchopulmonary disease
- •History of peptic ulcer disease or concurrent treatment with non-steroidal anti-inflammatory drugs
- •History of epileptic disorders
- •Renal insufficiency (glomerular filtration rate less than 60 mL/min according to the MDRD formula)
- •Hepatic insufficiency or transaminase levels greater than 5 times the normal upper limit
- •Conductance disorder characterized by electrocardiogram
- •QTc according to Bazett's formula greater than 480 ms on electrocardiogram
- •Current or recent (within three weeks prior to inclusion) psychotropic treatment (including antidepressants, to avoid interaction/potentiation in this population)
- •Treatment involving the following cytochromes: P450, P3A4, P2D6
- •Known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or any excipients of the investigational drug
- •Pregnant or breastfeeding woman
- •Person under legal protection measures
- •Person under guardianship measures
研究组 & 干预措施
donepezil 2.5 mg
Experimental
donepezil 2.5 mg daily for 90 days
干预措施: Donepezil 2.5 mg (Drug)
donepezil 5 mg
Experimental
donepezil 5 mg daily for 90 days
干预措施: Donepezil 5 mg (Drug)
placebo
Placebo Comparator
placebo daily for 90 days
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Effect on Body Mass Index in adult women suffering from anorexia nervosa
时间窗: Before (D0) and after 90 days of treatment
Difference of Body Masse Index between inclusion (D0) and the end of treatment (D90)
次要结局
- Effect on eating disorder symptomatology in adult women suffering from anorexia nervosa: difference of Eating Disorder Examination Questionnaire (EDE-Q) score(Before (D0) and after 90 days of treatment)
- Effects on habits learning in adult women suffering from anorexia nervosa: difference of phase 3 of slips-of-action neurocognitive test(Before (D0) and after 90 days of treatment)
- Effect on balance between goal-directed behaviors and habits in adult women suffering from anorexia nervosa: difference of total score in Self-Report Habit Index(Before (D0) and after 90 days of treatment)
- Effect on cognitive flexibility in adult women suffering from anorexia nervosa: difference in Wisconsin Card Sorting Test(Before (D0) and after 90 days of treatment)
- Effect on compulsive and obsessive in adult women suffering from anorexia nervosa: difference in Yale-Brown Obsessive Compulsive Scale(Before (D0) and after 90 days of treatment)
- Effect on cognitive flexibility in adult women suffering from anorexia nervosa: difference in Trail Making Test B-A, Brixton Test(Before (D0) and after 90 days of treatment)
- Effect on main eating disorder dimensions in adult suffering from anorexia nervosa: difference in subdimensions on EDE-Q and Eating Disorder Iventory 3(Before (D0) after 90 days of treatment and 90 days after stopping treatment)
- Effect on depressive and anxious symptoms in adult women suffering from anorexia nervosa: difference on Hospital Anxiety and Depression Scale (HADS)(Before (D0) and after 90 days of treatment)
- Measure the toxicity and tolerance of donepezil in adult women suffering from anorexia nervosa(D3, D5, D30, D90)
- Biological factors associated with response to treatment(Before (D0) and after 90 days of treatment)
研究者
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