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ID

30855

Description

This ODM file contains Documentation for structural MRI Scans and fMRI Scans. To be filled at Session 1 and 2 (Day 1). Study ID: 109710 Clinical Study ID: DAN109710 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief 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.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (1)
  1. 6/27/18 6/27/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

June 27, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    English

    MRI Scans (Sessions 1 and 2)

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Type of Visit
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    MRI Scan (Structural)
    Description

    MRI Scan (Structural)

    Alias
    UMLS CUI-1
    C0917711
    Has an MRI Scan been carried out?
    Description

    MRI Scan

    Data type

    text

    Alias
    UMLS CUI [1]
    C0917711
    If Yes, date of MRI Scan
    Description

    Date of MRI Scan

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0011008
    Start Time of MRI
    Description

    Start Time of MRI

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0024485
    Stop Time of MRI
    Description

    Stop Time of MRI

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C1522314
    Examination Number MRI
    Description

    Examination Number MRI

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0237753
    Briefly specify any abnormal situation which occurred during the scan (e.g., 'subject moved during scan', 'subject was coughing'). Leave blank if scan was completed without incident.
    Description

    Abnormal situation during scan

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024485
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C2745955
    fMRI 3 hrs post-dose
    Description

    fMRI 3 hrs post-dose

    Alias
    UMLS CUI-1
    C0376335
    UMLS CUI-2
    C0439568
    Has an fMRI Scan been carried out?
    Description

    fMRI scan

    Data type

    text

    Alias
    UMLS CUI [1]
    C0376335
    If Yes, date of fMRI scan
    Description

    date of fMRI scan

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0376335
    fMRI scan start time
    Description

    fMRI scan start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0376335
    fMRI scan stop time
    Description

    fMRI scan stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0376335
    Examination Number
    Description

    Examination Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0376335
    Briefly specify any abnormal situation which occurred during the scan (e.g., 'subject moved during scan', 'subject was coughing'). Leave blank if scan was completed without incident.
    Description

    Abnormal situation during scan

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0376335
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C2745955
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    Similar models

    MRI Scans (Sessions 1 and 2)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Type of Visit
    CL Item
    Session 1 (Day 1) (Session 1)
    CL Item
    Session 2 (Day 1) (Session 2)
    Item Group
    MRI Scan (Structural)
    C0917711 (UMLS CUI-1)
    Item
    Has an MRI Scan been carried out?
    text
    C0917711 (UMLS CUI [1])
    Planned relative Time
    Code List
    Has an MRI Scan been carried out?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Date of MRI Scan
    Item
    If Yes, date of MRI Scan
    date
    C0024485 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Start Time of MRI
    Item
    Start Time of MRI
    time
    C1301880 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    Stop Time of MRI
    Item
    Stop Time of MRI
    time
    C0024485 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Examination Number MRI
    Item
    Examination Number MRI
    text
    C0024485 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Abnormal situation during scan
    Item
    Briefly specify any abnormal situation which occurred during the scan (e.g., 'subject moved during scan', 'subject was coughing'). Leave blank if scan was completed without incident.
    text
    C0024485 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    Item Group
    fMRI 3 hrs post-dose
    C0376335 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Item
    Has an fMRI Scan been carried out?
    text
    C0376335 (UMLS CUI [1])
    Planned relative Time
    Code List
    Has an fMRI Scan been carried out?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    date of fMRI scan
    Item
    If Yes, date of fMRI scan
    date
    C0011008 (UMLS CUI [1,1])
    C0376335 (UMLS CUI [1,2])
    fMRI scan start time
    Item
    fMRI scan start time
    time
    C1301880 (UMLS CUI [1,1])
    C0376335 (UMLS CUI [1,2])
    fMRI scan stop time
    Item
    fMRI scan stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0376335 (UMLS CUI [1,2])
    Examination Number
    Item
    Examination Number
    text
    C0237753 (UMLS CUI [1,1])
    C0376335 (UMLS CUI [1,2])
    Abnormal situation during scan
    Item
    Briefly specify any abnormal situation which occurred during the scan (e.g., 'subject moved during scan', 'subject was coughing'). Leave blank if scan was completed without incident.
    text
    C0376335 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
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