ID

31426

Description

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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Versions (1)
  1. 8/21/18 8/21/18 -
Copyright Holder

GlaxoSmithKline

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August 21, 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

    English

    Investigational Product (Doses AM and PM) and Meal

    1 forms  
    Investigational Product (Dose a.m.)
    Description

    Investigational Product (Dose a.m.)

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

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

    Data type

    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.)
    Description

    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?
    Description

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

    Data type

    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.
    Description

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

    Data type

    text

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

    Investigational Product (Dose p.m.)

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

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

    Data type

    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.)
    Description

    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?
    Description

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

    Data type

    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.
    Description

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

    Data type

    text

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

    Meal (Breakfast)

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

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

    Data type

    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
    Description

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

    Data type

    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
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0439165
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    Similar models

    Investigational Product (Doses AM and PM) and Meal

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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