Neural mechanisms of lisdexamfetamine in binge eating disorder.
Understanding the neural mechanisms of Lisdexamfetamine dimesylate (LDX) pharmacotherapy in binge-eating disorder.
University of Sydney
62 participants
May 30, 2018
Interventional
Conditions
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.
Eligibility
Inclusion Criteria11
- 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.
- Age 18 – 40 years.
- Body Mass Index 20-45 kg/m2.
- Fluent in English.
- Have provided written informed consent.
Exclusion Criteria17
- 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.
- 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.
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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 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.
Locations(1)
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ACTRN12618000623291