Effects of the D3 Antagonist GSK598809 on Food Reward and Reinforcement
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GSK598809 Capsules; GSK598809 Placebo Capsules
Intervention type(s): Drug; Drug
Intervention description(s): GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.; Treatment of substance dependence and potentially other impulse control disorders.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Food Reward; fMRI; Obese; Cognition; Food Addiction; Behaviour; Overweight; Food Reinforcement; Metabolic endpoints