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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