ID

31426

Beschreibung

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

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  1. 21.08.18 21.08.18 -
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GlaxoSmithKline

Hochgeladen am

21. August 2018

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Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

Englisch

Investigational Product (Doses AM and PM) and Meal

1 Formulare  
Investigational Product (Dose a.m.)
Beschreibung

Investigational Product (Dose a.m.)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3174092
UMLS CUI-3
C4331833
Date/ time of dose
Beschreibung

Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Treatment Confirmation (Dose a.m.)
Beschreibung

Treatment Confirmation (Dose a.m.)

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
UMLS CUI-3
C4331833
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Therapeutic procedure; Correct (qualifier) | Medication dose; Interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C1272706
If subject did not receive correct treatment, please record reasons.
Beschreibung

Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Investigational Product (Dose p.m.)
Beschreibung

Investigational Product (Dose p.m.)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C3174092
UMLS CUI-3
C1509133
Date/ time of dose
Beschreibung

Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0040223
Treatment Confirmation (Dose p.m.)
Beschreibung

Treatment Confirmation (Dose p.m.)

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
UMLS CUI-3
C1509133
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Therapeutic procedure; Correct (qualifier) | Medication dose; Interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C1272706
If subject did not receive correct treatment, please record reasons.
Beschreibung

Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
Meal (Breakfast)
Beschreibung

Meal (Breakfast)

Alias
UMLS CUI-1
C1998602
Start Date and Time of Meal
Beschreibung

Meal (occasion for eating); Start Date | Meal (occasion for eating); Start time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1301880
End Date and Time of Meal
Beschreibung

Meal (occasion for eating); End date | Meal (occasion for eating); End Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1522314
Percentage of meal completed
Beschreibung

Meal (occasion for eating); Complete; Percent (qualifier value)

Datentyp

integer

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0439165
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Ähnliche Modelle

Investigational Product (Doses AM and PM) and Meal

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigational Product (Dose a.m.)
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C4331833 (UMLS CUI-3)
Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time
Item
Date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation (Dose a.m.)
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C4331833 (UMLS CUI-3)
Therapeutic procedure; Correct (qualifier) | Medication dose; Interval
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)
Item
If subject did not receive correct treatment, please record reasons.
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Investigational Product (Dose p.m.)
C0304229 (UMLS CUI-1)
C3174092 (UMLS CUI-2)
C1509133 (UMLS CUI-3)
Experimental drug; Dosage; Date in time | Experimental drug; Dosage; Time
Item
Date/ time of dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item Group
Treatment Confirmation (Dose p.m.)
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1509133 (UMLS CUI-3)
Therapeutic procedure; Correct (qualifier) | Medication dose; Interval
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C1272706 (UMLS CUI [2,2])
Therapeutic procedure; Correct (qualifier); Indication of (contextual qualifier)
Item
If subject did not receive correct treatment, please record reasons.
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Meal (Breakfast)
C1998602 (UMLS CUI-1)
Meal (occasion for eating); Start Date | Meal (occasion for eating); Start time
Item
Start Date and Time of Meal
datetime
C1998602 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Meal (occasion for eating); End date | Meal (occasion for eating); End Time
Item
End Date and Time of Meal
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Percentage of meal completed
integer
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
undefined item
Code List
Percentage of meal completed
CL Item
1 - 25% (1)
CL Item
26 - 50% (2)
CL Item
51 - 75% (3)
CL Item
76 - 100% (4)
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