ID

30998

Description

This ODM file contains a checklist for Completion of Questionnaires to be filled at the mentioned times during Session visits 1 and 2 (Day 1 each). 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 (Sessions 1+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
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Type of Visit
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Pre-Dose and 2h post-dose Questionnaires
Description

Pre-Dose and 2h post-dose Questionnaires

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C0034394
UMLS CUI-3
C0439572
Relative Time
Description

To be filled for both timepoints

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0034394
Has the Bond and Lader VAS been compeleted?
Description

Bond and Lader VAS

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0026516
If yes, Bond and Lader VAS 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]
C0003618
UMLS CUI [1,2]
C3536884
If yes, Appetite VAS Scores
Description

Appetite VAS Scores

Data type

text

Alias
UMLS CUI [1,1]
C0003618
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0449820
Has a Distress VAS been completed?
Description

Distress VAS

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
If yes, Distress VAS Score(s)
Description

Distress VAS Score

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
UMLS CUI [1,3]
C0449820
Has the Barnes Akathisia Scale (BAS) been completed?
Description

Barnes Akathisia Scale

Data type

text

Alias
UMLS CUI [1]
C3541345
If yes, Barnes Akathisia Scale (BAS) Score(s)
Description

Barnes Akathisia Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C3541345
UMLS CUI [1,2]
C0449820
Has the Simpson Angus EPS Scale been completed?
Description

Simpson Angus EPS Scale

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0015371
If yes, Simpson Angus EPS Scale Score(s)
Description

Simpson Angus EPS Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0015371
UMLS CUI [1,4]
C0449820
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
Description

Abnormal Involuntary Movement Scale

Data type

text

Alias
UMLS CUI [1]
C0450978
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
Description

Abnormal Involuntary Movement Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0450978
UMLS CUI [1,2]
C0449820
4 and 10 h post-dose Questionnaires
Description

4 and 10 h post-dose Questionnaires

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0439574
UMLS CUI-3
C0439568
UMLS CUI-4
C0040223
Relative Time
Description

Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0034394
Has the Distress VAS been compeleted?
Description

Distress VAS

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
If yes, Distress VAS Score
Description

Distress VAS Score

Data type

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
UMLS CUI [1,3]
C0449820
5, (8), 24 hrs post-Dose questionnaires
Description

5, (8), 24 hrs post-Dose questionnaires

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0040223
UMLS CUI-3
C0034394
Relative Time of Questionnaires
Description

At 8 hrs post-dose only neccessary if abnormal at 5 hrs post-dose. 5 and 24 hrs post-dose mandatory.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0034394
Has the Barnes Akathisia Scale (BAS) been completed?
Description

"X" only if not neccessary at 8 hrs post dose.

Data type

text

Alias
UMLS CUI [1]
C3541345
If yes, Barnes Akathisia Scale (BAS) Score(s)
Description

Barnes Akathisia Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C3541345
UMLS CUI [1,2]
C0449820
Has the Simpson Angus EPS Scale been completed?
Description

"X" only if not neccessary at 8 hrs post dose.

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0015371
If yes, Simpson Angus EPS Scale Score(s)
Description

Simpson Angus EPS Scale Score(s)

Data type

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0041755
UMLS CUI [1,3]
C0015371
UMLS CUI [1,4]
C0449820
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
Description

"X" only if not neccessary at 8 hrs post dose.

Data type

text

Alias
UMLS CUI [1]
C0450978
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
Description

"X" only if not neccessary at 8 hrs post dose.

Data type

text

Alias
UMLS CUI [1,1]
C0450978
UMLS CUI [1,2]
C0449820
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Similar models

Questionnaire Checklist (Sessions 1+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])
Date of Visit
Item
Date of Visit
date
C1320303 (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 (Day 1))
CL Item
Session 2 (Day 1) (Session 2 (Day 1))
Item Group
Pre-Dose and 2h post-dose Questionnaires
C0439565 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0439572 (UMLS CUI-3)
Item
Relative Time
text
C0439564 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Relative Time
CL Item
Pre-dose (Pre-dose)
CL Item
2h post-dose (2h post-dose)
Item
Has the Bond and Lader VAS been compeleted?
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?
CL Item
Yes (Y)
CL Item
No (N)
Bond and Lader VAS Score(s)
Item
If yes, Bond and Lader VAS Score(s)
text
C0681889 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item
Has an Appetite VAS been completed?
text
C0003618 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has an Appetite VAS been completed?
CL Item
Yes (Y)
CL Item
No (N)
Appetite VAS Scores
Item
If yes, Appetite VAS Scores
text
C0003618 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item
Has a Distress VAS been completed?
text
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has a Distress VAS been completed?
CL Item
Yes (Y)
CL Item
No (N)
Distress VAS Score
Item
If yes, Distress VAS Score(s)
text
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item
Has the Barnes Akathisia Scale (BAS) been completed?
text
C3541345 (UMLS CUI [1])
Bond and Lader VAS
Code List
Has the Barnes Akathisia Scale (BAS) been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Barnes Akathisia Scale (BAS) Score(s)
text
C3541345 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
If yes, Barnes Akathisia Scale (BAS) Score(s)
Item
Has the Simpson Angus EPS Scale been completed?
text
C0681889 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
Has the Simpson Angus EPS Scale been completed?
CL Item
Yes (Y)
CL Item
No (N)
Simpson Angus EPS Scale Score(s)
Item
If yes, Simpson Angus EPS Scale Score(s)
text
C0681889 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Item
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
text
C0450978 (UMLS CUI [1])
Bond and Lader VAS
Code List
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
text
C0450978 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
Item Group
4 and 10 h post-dose Questionnaires
C0034394 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Item
Relative Time
text
C0439564 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
Relative Time
Code List
Relative Time
CL Item
4 hrs post dose (4 hrs post dose)
CL Item
10 hrs post dose (10 hrs post dose)
Item
Has the Distress VAS been compeleted?
text
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
Has the Distress VAS been compeleted?
CL Item
Yes (Y)
CL Item
No (N)
Item
If yes, Distress VAS Score
text
C3536884 (UMLS CUI [1,1])
C0231303 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
If yes, Distress VAS Score
Item Group
5, (8), 24 hrs post-Dose questionnaires
C0439568 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
C0034394 (UMLS CUI-3)
Item
Relative Time of Questionnaires
text
C0439564 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
Relative Time
Code List
Relative Time of Questionnaires
CL Item
5 hrs post-dose (5 hrs post-dose)
CL Item
8 hrs post-dose (8 hrs post-dose)
CL Item
24 hrs post-dose (24 hrs post-dose)
Item
Has the Barnes Akathisia Scale (BAS) been completed?
text
C3541345 (UMLS CUI [1])
Bond and Lader VAS
Code List
Has the Barnes Akathisia Scale (BAS) been completed?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
CL Item
Not Applicable (8hrs post-dose) (X)
(Comment:en)
Barnes Akathisia Scale Score(s)
Item
If yes, Barnes Akathisia Scale (BAS) Score(s)
text
C3541345 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item
Has the Simpson Angus EPS Scale been completed?
text
C0681889 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
Bond and Lader VAS
Code List
Has the Simpson Angus EPS Scale been completed?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
CL Item
Not Applicable (8hrs post-dose) (X)
(Comment:en)
Simpson Angus EPS Scale Score(s)
Item
If yes, Simpson Angus EPS Scale Score(s)
text
C0681889 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
Item
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
text
C0450978 (UMLS CUI [1])
Bond and Lader VAS
Code List
Has the Abnormal Involuntary Movement Scale (AIMS) been completed?
CL Item
Yes (Y)
(Comment:en)
CL Item
No (N)
(Comment:en)
CL Item
Not Applicable (8hrs post-dose) (X)
(Comment:en)
Item
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
text
C0450978 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Bond and Lader VAS
Code List
If yes, Abnormal Involuntary Movement Scale (AIMS) Score(s)
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