None listed
Conditions
Brief summary
While Lisdexamfetamine dimesylate (LDX) is indicated for moderate to severe binge-eating disorder (BED) in Australia, the exact mode of its therapeutic action in BED remains unknown. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that: 1. LDX will act by altering connectivity within and between brain circuits responsible for reward and inhibition. 2. A reduction in binge-eating behaviours will correlate with increased activity and connectivity of brain regions within reward and inhibition circuits.
Interventions
Drug name: Lisdexamfetamine dimesylate
Mode of administration: oral tablet
Dose and duration of administration: Intervention is planned to be titrated. All binge-eating disorder patients will commence with 30mg once daily for 2 weeks, then increase to 50mg once daily for the next 2 weeks following a blood pressure check. At 4-weeks, all participants will receive a safety and dose check by a study clinician. The clinician will assess whether those responsive to the medication should maintain thei
Drug name: Lisdexamfetamine dimesylate Mode of administration: oral tablet Dose and duration of administration: Intervention is planned to be titrated. All binge-eating disorder patients will commence with 30mg once daily for 2 weeks, then increase to 50mg once daily for the next 2 weeks following a blood pressure check. At 4-weeks, all participants will receive a safety and dose check by a study clinician. The clinician will assess whether those responsive to the medication should maintain their dose of 50mg once daily for the next 4 weeks, or whether those non-responsive should increase their dose to 70mg once daily for the next 4 weeks. Strategies used to monitor adherence to the intervention will include: - Participant diary to be completed daily, including a checkbox for medication compliance. - Participants will be required to return all medication blister packs (used or unused) at the follow-up session, which will be counted for compliance rate. If less than 60% of tablets have been taken at this point, this will be viewed as non-compliant.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed