eural mechanisms of lisdexamfetamine in binge eating disorder.
- Conditions
- Binge-Eating DisorderMental Health - Eating disorders
- Registration Number
- ACTRN12618000623291
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in resting-state functional connectivity between reward and inhibition networks in participants on LDX after 8 weeks of treatment, relative to pre-treatment, as assessed by MRI scans.[Baseline; 8 weeks after LDX treatment commencement.];Changes in resting-state functional connectivity between reward and inhibition networks in participants on LDX after 8 weeks of treatment, relative to no-treatment controls, as assessed by MRI scans.[Baseline; 8 weeks after LDX treatment commencement.]
- Secondary Outcome Measures
Name Time Method Changes in binge-eating symptoms, as assessed by the number of binge-eating events in the past week in a self-report diary.[Baseline; 8 weeks after LDX treatment commencement.];Changes in functional connectivity between reward and inhibition networks.[Baseline; 8 weeks after LDX treatment commencement.]