ID

30550

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.

Lien

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

Mots-clés

Versions (2)
  1. 13/06/2018 13/06/2018 - Sarah Riepenhausen
  2. 09/07/2018 09/07/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

13 juin 2018

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Questionnaire Checklist (Sessions 1+2)

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Type of Visit
Description

Visit

Type de données

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

Type de données

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

Type de données

text

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

Appetite VAS

Type de données

text

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

Distress VAS

Type de données

text

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

Barnes Akathisia Scale

Type de données

text

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

Simpson Angus EPS Scale

Type de données

text

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

Abnormal Involuntary Movement Scale

Type de données

text

Alias
UMLS CUI [1]
C0450978
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

Type de données

text

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

Distress VAS

Type de données

text

Alias
UMLS CUI [1,1]
C3536884
UMLS CUI [1,2]
C0231303
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.

Type de données

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.

Type de données

text

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

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

Type de données

text

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

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

Type de données

text

Alias
UMLS CUI [1]
C0450978
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Similar models

Questionnaire Checklist (Sessions 1+2)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
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)
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)
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
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)
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 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 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)
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)
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)
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