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Completed

NCT Number: NCT01039454

Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement

This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

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Key information

Conditions

Substance Dependence Behavior Behavior, Addictive Body Weight Chemically-Induced Disorders Compulsive Behavior Feeding and Eating Disorders Food Addiction Impulsive Behavior Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

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About this study

This novel compound is being developed for the treatment of substance dependence and potentially other impulse control disorders.

This is an fMRI study designed to examine the behavioural and physiological effects of a single dose of novel compound on food reward and reinforcement in relation to food seeking behaviour under conditions of fasting, using fMRI, neurocognitive and metabolic endpoints in overweight and obese subjects. These main objectives will be evaluated in the principal part of the study, Part A. The study will also consist of a follow up period of weight management with a dietician where exploratory objectives are considered, Part B.

Part A, will be a single-blind, randomised, placebo controlled, multi-centre, two-period cross-over study. Approximately 24 subjects will be enrolled such that a minimum of 20 subjects complete dosing and critical assessments. All subjects will be required to complete questionnaires, perform a series of behavioural tasks and scanning procedures. Safety and tolerability will be assessed by monitoring subjects for adverse events, vital signs, ECGs, movement disorders (EPS, Akathisia) and laboratory parameters. The pharmacokinetic profile of the compound in this subject population will be determined by blood sampling over a 72 hour period post dosing, in both sessions. Part B will consist of 12 weeks weight management directed by a dietician on an outpatient basis. Subjects will have fortnightly visits with a dietician and at the end of the 12 weeks complete three questionnaires (TFEQ-18R, DBEQ and YBOCS-BE) and have their weight measured to assess weight loss.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • generally healthy
  • right handed
  • binge eating episode
  • use appropriate contraception method
  • willing to see a dietician
  • overweight or obese (BMI 27 - 40 kg/m2)

Exclusion criteria

  • pregnant or breast feeding female
  • recent weight loss or gain
  • recent use of weight loss drugs
  • surgery for obesity
  • abuse alcohol or drugs
  • cannot do MRI scans
  • smokers
  • certain emotional problems being treated with medications
  • medical, surgical or neuropsychiatric illness
  • ECG abnormality
  • sudden unexplained death or syncope in first degree relatives

Treatment and study plan

GSK598809 Capsules

Drug

GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.

GSK598809 Placebo Capsules

Drug

Treatment of substance dependence and potentially other impulse control disorders.

Primary outcomes

  1. Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task

    Time frame: 9 weeks

  2. Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task.

    Time frame: 9 weeks

Secondary outcomes

  1. Appetite VAS, Bond and Lader VAS, Distress VAS, BIS II, TFEQ, BIS/BAS, BDI-II, Body weight, Metabolic markers: plasma leptin, ghrelin, alpa MSH

    Time frame: 9 weeks

  2. PK endpoints: AUC, Cmax, tmax, t1/2

    Time frame: 9 weeks

  3. Safety and tolerability: adverse events, laboratory values, cardiovascular - blood pressure; heart rate; ECGs, movement disorders, temperature, respiratory rate, serum prolactin, GH and TSH

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Single-blind, Randomized, Placebo Controlled, Two-period Crossover fMRI Study to Investigate the Effects of the D3 Antagonist GSK598809 on Neural and Behavioural Responses to Food Reward and Reinforcement After a Single Oral Dose of GSK598809 in Overweight and Obese Subjects.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 25, 2009
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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