ACTRN12618000623291招募中4 期
nderstanding the neural mechanisms of Lisdexamfetamine dimesylate (LDX) pharmacotherapy in binge-eating disorder.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •The key inclusion criteria for BED patients are:
- •- Age 18 – 40 years.
- •- Binge-eating disorder diagnosis, confirmed by the eating disorders module of the Structured Clinical Interview for DSM 5.
- •- Moderate to severe BED, defined as the presence of binge eating frequency of 3 days/week or greater in the month prior to the baseline assessment and a score of 4 or greater on the clinical global impressions severity scale.
- •- Body mass index of 20 – 45kg/m2.
- •- A study doctor has verified that it is medically and psychiatrically safe for their patient to commence LDX.
- •- Fluent in English.
- •- Have provided written informed consent.
- •The key inclusion criteria for control participants are:
- •- Age 18 – 40 years.
- •- Body Mass Index 20-45 kg/m2.
- •- Fluent in English.
- •- Have provided written informed consent.
排除标准
- •The key exclusion criteria for BED patients are:
- •- Current anorexia or bulimia nervosa.
- •- History of psychosis or mania.
- •- Pregnant or breast-feeding women.
- •- Current therapy with antipsychotics or norepinephrine reuptake inhibitors.
- •- Cardiovascular disease, hypertension, use of monoamine oxidase inhibitors (MAOIs), or any other contraindications for psychostimulants.
- •- History of substance abuse/dependence (excluding nicotine).
- •- Previous suicide attempts or current suicidal ideation.
- •- Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put BED patients at increased risk when exposed to optimal doses of the drug treatment. For example, hypertension or a diagnosis of epilepsy would exclude a patient from this trial.
- •- Use of a psychostimulant in the 6 months prior to the study.
- •- Inability to tolerate the MRI scanner due to physical or psychological factors.
- •- History of physical brain injury or blow to the head that resulted in loss of consciousness for at least 10 minutes.
- •The key exclusion criteria for control participants are:
- •- Current or previous diagnosis of an eating disorder or any other psychiatric diagnosis, including substance dependence.
- •- Pregnant or breast-feeding women.
- •- Inability to tolerate the MRI scanner due to physical or psychological factors.
- •- Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put subjects at increased risk.
- •- History of physical brain injury or blow to the head that resulted in loss of consciousness for at least 10 minutes.
- •- Prior treatment with any stimulant medication.
研究者
相似试验
招募中
3 期
Assessment of the effect of lisdexamfetamine on fatigue in patients with multiple sclerosisMultiple sclerosisIRCT20230125057221N1Tehran University of Medical Sciences52
终止
4 期
Lisdexamfetamine's Effect In ADHD in the Brain and CognitionAttention Deficit Hyperactivity DisorderNCT02170298University of California, Davis6
进行中（未招募）
1 期
nderstanding the Neurobiology of Pharmacologically-induced Acute Stress on Ethical DecisionsMimic an acute stress response in humans.CTIS2023-508731-31-01niversitair Medisch Centrum Utrecht100
终止
不适用
Effects of LDX on Cognitive Processes and AppetiteBinge EatingEating BehaviorNCT04181957University of Birmingham22
招募中
不适用
Dexamphetamine modulation of brainwave activity and prepulse inhibition in healthy participantsMental Health - Studies of normal psychology, cognitive function and behaviourSchizophreniaACTRN12608000610336Mathew Martin-Iverson30