Effects of LDX on Cognitive Processes and Appetite

N/ATerminatedNCT04181957

University of Birmingham22 enrolled

Overview

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

This study will investigate the specific reward and cognitive mechanisms that mediate the effects of LDX on eating in participants with sub-clinical binge-eating disorder symptoms. A sub-clinical sample will be recruited in line with the Research Domain Criteria Initiative established by the US National Institute of Mental Health which encourages research on dimensions of observable behaviour rather than a categorical, symptom-based approach to the study of mental health. The tendency towards binge-like eating will be modelled using an eating in the absence of hunger paradigm in which participants consume a pasta meal and are then offered the opportunity to consume as many palatable cookies as they like. Reward processes will be assessed by measuring neural and behavioural responses to palatable food pictures using functional Magnetic Resonance Imaging (fMRI). Responses to emotional stimuli will be assessed using the P1vital® Oxford Emotional Test Battery. Impulsive responding will be assessed using the delay discounting task and the stop signal task. Attentional processing will be assessed using the sustained performance task and working memory will be assessed with the n-back task.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Binge Eating Eating Behavior

Interventions

Placebo oral tabletDRUG

Participants take one dose of placebo (lactose) tablet.

Lisdexamfetamine DimesylateDRUG

Participants take one 50mg tablet of lisdexamfetamine dimesylate once.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Birmingham

Birmingham, United Kingdom

Outcomes

Primary Outcomes

Metabolic food intake

We will examine if LDX has an influence on metabolic food intake using a lab-based food task, in which participants eat as much pasta as they like until they feel comfortably full . Amount eaten will be measured in grams.

Time frame: 15 minutes

Hedonic food intake

The effect of LDX on hedonic food intake will be measured via offering a palatable snack of chocolate chip cookies 20 minutes after participants have consumed the pasta. Amount eaten will be measured in grams.

Time frame: 15 minutes

Secondary Outcomes

fMRI Reward Processes

We will investigate the effect of LDX on neural responses to food stimuli using fMRI, and if/how liking ratings modulate these responses. The participants will perform a food and non-food rating task in the scanner, to measure reward-responses. Participants will view a range (36 each category) of high -and low-calorie food (equally distributed in sweet and savoury), and non-food items (visually matched). All items will be scored for appealing/liking with the use of a button box, varying from 1 (not at all) to 5 (very much). Each item will be presented for 3000ms followed by a fixation cross (500 - 1500ms). (3 x 7 min = 21 min)

Time frame: 21 minutes

Ratings

We will determine if LDX administration has an effect on appetite and mood ratings via a visual analogue scale (VAS) in a hungry and sated state. Participants will drag a cursor from 0cm (not at all) to 10cm (most I could imagine) to self-report mood and appetite.

Time frame: 20 minutes

Emotional processing

We will determine if LDX modulates emotional processing. The ETB is a computerised battery that comprises the following tasks: FERT: Faces will appear on a screen ranging in emotions. The participant is instructed to classify each expression as quickly and accurately as possible. Accuracy, response bias, reaction time, and target sensitivity. ECAT: 60 positive and negative adjectives will be presented for the participant to indicate if they would like to be described as such. Accuracy and reaction times. EREC: The participants will be asked to recall as many words from the ECAT as can be remembered within a 4-minute period. The number of correct words recalled and respective valence will be measured. EMEM: Participants will be presented with personality descriptors derived from the ECAT, along with matching novel distractor words. Participants will indicate if the descriptor was presented before. Accuracy, reaction time, response bias, and target sensitivity.

Data from ClinicalTrials.gov

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