Effects of LDX on Cognitive Processes and Appetite

• Status: Terminated
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: Female

Summary

This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Birmingham
• Treatments: Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• Fluent English speakers

• Be willing to be informed of chance pathological findings from the fMRI scan

• Must have binge-eating symptoms that is measured by a minimum score of 18 on the Binge Eating Scale

• Must have a minimum BMI of 18.5

• Must be below 152.4kg

• Must have clearance from a qualified physician before participating

Exclusion Criteria:

• Symptoms or diagnosis of other eating disorders.

• Psychotherapy and/or pharmacotherapy for binge-eating disorder (BED) 3 months before the study, as this will suggest a diagnosis of BED and may influence eating behaviour.

• Metabolic (e.g. metabolic disorder, diabetes), psychological (e.g. depression), substance, or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases

• Intake of any medication that can interfere with the drug or measurements, determined through questionnaires in the screening session

• Current smoking, as it can interfere with appetite

• Current pregnancy or breastfeeding

• Not passing a breathalyser test on the morning of testing.

• Food allergies (e.g. peanut allergy, lactose and gluten intolerance) or vegetarian/vegan diet

• Disliking the study lunch to ensure that participants will consume the provided food

• Women will be asked to participate only in weeks when they are not menstruating or in their pre-menstrual week, to avoid hormonal disruption to appetite.

The following are exclusion criteria are specific to the MRI scanner:

• Non-removable metal object in or on their body, such as: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces

• Left-handed

• Tattoos that are older than 10 years

• Claustrophobia

• Limited temperature perception and/or increased sensitivity to warming of the body

• Pathological hearing ability or an increased sensitivity to loud noises

• Operation less than three months ago

• Simultaneous participation in other studies that involve drug intake or blood sampling

• Acute illness or infection during the last 4 weeks

• Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome) to ensure medical fitness to participate

• Moderate or severe head injury