Last updated: 11/07/2018 02:45:27

Effects of the D3 antagonist GSK598809 on food reward and reinforcement

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GSK study ID
109710
See study documents
Clinicaltrials.gov ID
NCT01039454
EudraCT ID
2008-004918-26
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 9 weeks

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

Timeframe: 9 weeks

Secondary outcomes:

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

Timeframe: 9 weeks

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

Timeframe: 9 weeks

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

Timeframe: 9 weeks

Interventions:
  • Drug: GSK598809 Capsules
  • Drug: GSK598809 Placebo Capsules
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Karin Mogg, Brendan P. Bradle, Barry O’Neill, Massimo Bani, Emilio Merlo-Pich, Annelize Koch, Edward T. Bullmore, Pradeep J. Nathan. Effect of dopamine D3 receptor antagonism on approach responses to food cues in overweight and obese individuals .Behav Pharmacol.2012;23(5-6):603-608
    Medical condition
    Substance Dependence
    Product
    GSK598809
    Collaborators
    GSK
    Study date(s)
    December 2008 to April 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • generally healthy
    • right handed
    • pregnant or breast feeding female
    • recent weight loss or gain
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7EW
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-26-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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