ID

30997

Description

This ODM file contains a checklist for Completion of Questionnaires for the Screening Visit. 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 (2)
  1. 6/13/18 6/13/18 - Sarah Riepenhausen
  2. 7/9/18 7/9/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

July 9, 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

Questionnaire Checklist (Screening)

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
Date of Screening Visit
Description

Date of Screening Visit

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C1710477
Questionnaires at Screening
Description

Questionnaires at Screening

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C1710477
Has the Bond and Lader VAS been compeleted at this visit?
Description

Bond and Lader VAS

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0026516
If yes, Bond and Lader Score(s)
Description

Bond and Lader VAS Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0026516
UMLS CUI [1,3]
C0449820
Has an Appetite VAS been completed?
Description

Appetite VAS

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0003618
If yes, Appetite VAS Score(s)
Description

Appetite VAS Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0003618
UMLS CUI [1,3]
C0449820
Has a Barratt Impulsiveness Scale been completed?
Description

Barratt Impulsiveness Scale

Data type

text

Alias
UMLS CUI [1,1]
C0564567
UMLS CUI [1,2]
C0681889
If yes, Barratt Impulsiveness Scale Score(s)
Description

Barratt Impulsiveness Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0564567
UMLS CUI [1,2]
C0681889
UMLS CUI [1,3]
C0449820
Has a Three Factor Eating Questionnaire been completed?
Description

Three Factor Eating Questionnaire

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0013473
If yes, Three Factor Eating Questionnaire Score(s)
Description

Three Factor Eating Questionnaire Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0013473
UMLS CUI [1,3]
C0449820
Has a Dutch Eating Behaviour Questionnaire been completed?
Description

Dutch Eating Behaviour Questionnaire

Data type

text

Alias
UMLS CUI [1,1]
C4021982
UMLS CUI [1,2]
C0034394
If yes, Dutch Eating Behaviour Questionnaire Score(s)
Description

Dutch Eating Behaviour Questionnaire Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C4021982
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0449820
Has a Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) been completed?
Description

Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating

Data type

text

Alias
UMLS CUI [1,1]
C0596170
UMLS CUI [1,2]
C0814231
If yes, Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score(s)
Description

Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0596170
UMLS CUI [1,2]
C0814231
UMLS CUI [1,3]
C0449820
Has a Behavioural Inhibition/Activation Scale (BIS/BAS) been completed?
Description

Behavioural Inhibition/Activation Scale

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C2253866
UMLS CUI [1,3]
C2253870
If yes, Behavioural Inhibition/Activation Scale (BIS/BAS) Score(s)
Description

Behavioural Inhibition/Activation Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C2253866
UMLS CUI [1,3]
C2253870
UMLS CUI [1,4]
C0449820
Has a Beck Depression Inventory II been completed?
Description

BDI-II

Data type

text

Alias
UMLS CUI [1]
C4273555
If yes, Beck Depression Inventory II Score(s)
Description

BDI-II Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C4273555
UMLS CUI [1,2]
C0449820
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Similar models

Questionnaire Checklist (Screening)

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])
Date of Screening Visit
Item
Date of Screening Visit
date
C1320303 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Questionnaires at Screening
C0034394 (UMLS CUI-1)
C1710477 (UMLS CUI-2)
Item
Has the Bond and Lader VAS been compeleted at this visit?
text
C0681889 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has the Bond and Lader VAS been compeleted at this visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Bond and Lader Score(s)
text
C0681889 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
If yes, Bond and Lader Score(s)
Item
Has an Appetite VAS been completed?
text
C3536884 (UMLS CUI [1,1])
C0003618 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has an Appetite VAS been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Appetite VAS Score(s)
text
C3536884 (UMLS CUI [1,1])
C0003618 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
If yes, Appetite VAS Score(s)
Item
Has a Barratt Impulsiveness Scale been completed?
text
C0564567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has a Barratt Impulsiveness Scale been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Barratt Impulsiveness Scale Score(s)
text
C0564567 (UMLS CUI [1,1])
C0681889 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
If yes, Barratt Impulsiveness Scale Score(s)
Item
Has a Three Factor Eating Questionnaire been completed?
text
C0034394 (UMLS CUI [1,1])
C0013473 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has a Three Factor Eating Questionnaire been completed?
CL Item
Yes (Y)
CL Item
No (N)
Three Factor Eating Questionnaire Score(s)
Item
If yes, Three Factor Eating Questionnaire Score(s)
text
C0034394 (UMLS CUI [1,1])
C0013473 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item
Has a Dutch Eating Behaviour Questionnaire been completed?
text
C4021982 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has a Dutch Eating Behaviour Questionnaire been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Dutch Eating Behaviour Questionnaire Score(s)
text
C4021982 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
If yes, Dutch Eating Behaviour Questionnaire Score(s)
Item
Has a Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) been completed?
text
C0596170 (UMLS CUI [1,1])
C0814231 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has a Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) been completed?
CL Item
Yes (Y)
CL Item
No (N)
Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating Score(s)
Item
If yes, Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Score(s)
text
C0596170 (UMLS CUI [1,1])
C0814231 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item
Has a Behavioural Inhibition/Activation Scale (BIS/BAS) been completed?
text
C0681889 (UMLS CUI [1,1])
C2253866 (UMLS CUI [1,2])
C2253870 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
Has a Behavioural Inhibition/Activation Scale (BIS/BAS) been completed?
CL Item
Yes (Y)
CL Item
No (N)
Behavioural Inhibition/Activation Scale Score(s)
Item
If yes, Behavioural Inhibition/Activation Scale (BIS/BAS) Score(s)
text
C0681889 (UMLS CUI [1,1])
C2253866 (UMLS CUI [1,2])
C2253870 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Item
Has a Beck Depression Inventory II been completed?
text
C4273555 (UMLS CUI [1])
Bond and Lader VAS
Code List
Has a Beck Depression Inventory II been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Beck Depression Inventory II Score(s)
text
C4273555 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
If yes, Beck Depression Inventory II Score(s)
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