ID

30997

Beskrivning

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.

Länk

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

Nyckelord

Versioner (2)
  1. 2018-06-13 2018-06-13 - Sarah Riepenhausen
  2. 2018-07-09 2018-07-09 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 juli 2018

DOI

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Licens

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

Engelsk

Questionnaire Checklist (Screening)

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Screening Visit
Beskrivning

Date of Screening Visit

Datatyp

date

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

Questionnaires at Screening

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

Bond and Lader VAS

Datatyp

text

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

Bond and Lader VAS Score(s)

Datatyp

text

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

Appetite VAS

Datatyp

text

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

Appetite VAS Score(s)

Datatyp

text

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

Barratt Impulsiveness Scale

Datatyp

text

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

Barratt Impulsiveness Scale Score(s)

Datatyp

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?
Beskrivning

Three Factor Eating Questionnaire

Datatyp

text

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

Three Factor Eating Questionnaire Score(s)

Datatyp

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?
Beskrivning

Dutch Eating Behaviour Questionnaire

Datatyp

text

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

Dutch Eating Behaviour Questionnaire Score(s)

Datatyp

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?
Beskrivning

Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating

Datatyp

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)
Beskrivning

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

Datatyp

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?
Beskrivning

Behavioural Inhibition/Activation Scale

Datatyp

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)
Beskrivning

Behavioural Inhibition/Activation Scale Score(s)

Datatyp

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?
Beskrivning

BDI-II

Datatyp

text

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

BDI-II Score(s)

Datatyp

text

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

Questionnaire Checklist (Screening)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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