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ID

29783

Description

Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 4 - Visit 6.

Link

https://clinicaltrials.gov/ct2/show/NCT00086593

Keywords

Versions (1)
  1. 4/19/18 4/19/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 19, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

    English

    Week 4 - Visit 6

    1 forms  
    1. StudyEvent: ODM
      1. Week 4 - Visit 6
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0518766
    Subject Position
    Description

    Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1262869
    UMLS CUI [1,2]
    C0518766
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Psychiatric Evaluation
    Description

    Psychiatric Evaluation

    Alias
    UMLS CUI-1
    C0846574
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    Description

    Positive and Negative Syndrome Scale (PANSS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451383
    Total score of "Scale for the Assessment of Negative Symptoms"
    Description

    5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C4511599
    UMLS CUI [1,2]
    C0681889
    UMLS CUI [1,3]
    C0036341
    Score of "Calgary Depression Scale for Schizophrenia"
    Description

    Calgary Depression Scale for Schizophrenia (CDSS)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0679604
    UMLS CUI [1,2]
    C0036341
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Description

    Clinicians Global Impressions - Severity (CGI-S)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639887
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    Description

    Clinicians Global Impressions - Improvement (CGI-I)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639888
    Score of "Simpson Angus Scale"
    Description

    Simpson Angus Scale

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0681889
    UMLS CUI [1,2]
    C0041755
    UMLS CUI [1,3]
    C0015371
    Score of "Barnes Akathisia Scale"
    Description

    The Barnes Akathisia Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3541345
    Score of "Abnormal Involuntary Movement Scale"
    Description

    Abnormal Involuntary Movement Scale (AIMS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0450978
    Pharmacokinetic Sampling
    Description

    Pharmacokinetic Sampling

    Sampling Date
    Description

    Sample No.: BLD003

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0201734
    Sampling TIme
    Description

    Sampling Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0201734
    Blood Sample taken?
    Description

    Sample No.: BLD003

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0201734
    Atypical Antipsychotic Dosing
    Description

    Atypical Antipsychotic Dosing

    Alias
    UMLS CUI-1
    C0040615
    UMLS CUI-2
    C0205182
    UMLS CUI-3
    C0178602
    Drug Name
    Description

    Drug Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C1276996
    Was this atypical antipsychotic medication taken?
    Description

    Taking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952
    UMLS CUI [1,2]
    C1276996
    Date dose taken
    Description

    Date dose taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1276996
    Time dose taken
    Description

    Time dose taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1276996
    Investigational Product dosing
    Description

    Investigational Product dosing

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0678766
    Date dose taken
    Description

    Planned relative Time: Day before Clinic Visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0178602
    UMLS CUI [1,4]
    C0011008
    Time dose taken
    Description

    Time dose taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0013227
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    Similar models

    Week 4 - Visit 6

    1 forms
    1. StudyEvent: ODM
      1. Week 4 - Visit 6
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Item
    Subject Position
    integer
    C1262869 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Subject Position
    Code List
    Subject Position
    CL Item
    Sitting (1)
    CL Item
    Standing (2)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Psychiatric Evaluation
    C0846574 (UMLS CUI-1)
    Positive and Negative Syndrome Scale (PANSS)
    Item
    Total Score in Positive and Negative Syndrome Scale (PANSS)
    integer
    C0451383 (UMLS CUI [1])
    Scale for the Assessment of Negative Symptoms (SANS)
    Item
    Total score of "Scale for the Assessment of Negative Symptoms"
    integer
    C4511599 (UMLS CUI [1,1])
    C0681889 (UMLS CUI [1,2])
    C0036341 (UMLS CUI [1,3])
    Calgary Depression Scale for Schizophrenia (CDSS)
    Item
    Score of "Calgary Depression Scale for Schizophrenia"
    integer
    C0679604 (UMLS CUI [1,1])
    C0036341 (UMLS CUI [1,2])
    Clinicians Global Impressions - Severity (CGI-S)
    Item
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    integer
    C3639887 (UMLS CUI [1])
    Clinicians Global Impressions - Improvement (CGI-I)
    Item
    Score of Clinicians Global Impressions, Part Improvement (CGI-I)
    integer
    C3639888 (UMLS CUI [1])
    Simpson Angus Scale
    Item
    Score of "Simpson Angus Scale"
    integer
    C0681889 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    C0015371 (UMLS CUI [1,3])
    The Barnes Akathisia Scale
    Item
    Score of "Barnes Akathisia Scale"
    integer
    C3541345 (UMLS CUI [1])
    Abnormal Involuntary Movement Scale (AIMS)
    Item
    Score of "Abnormal Involuntary Movement Scale"
    integer
    C0450978 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Sampling
    Sampling Date
    Item
    Sampling Date
    date
    C0178913 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    Sampling Time
    Item
    Sampling TIme
    time
    C0040223 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0201734 (UMLS CUI [1,3])
    Blood Sample
    Item
    Blood Sample taken?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0201734 (UMLS CUI [1,2])
    Item Group
    Atypical Antipsychotic Dosing
    C0040615 (UMLS CUI-1)
    C0205182 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C1276996 (UMLS CUI [1,2])
    Drug Name
    Code List
    Drug Name
    CL Item
    Abilify (aripiprazole) (Abilify (aripiprazole))
    CL Item
    Clozaril (clozapine) (Clozaril (clozapine))
    CL Item
    Geodon (ziprasidone) (Geodon (ziprasidone))
    CL Item
    Risperdal (risperidone) (Risperdal (risperidone))
    CL Item
    Seroquel (quetiapine fumarate) (Seroquel (quetiapine fumarate))
    CL Item
    Zyprexa/Zydis (olanzapine) (Zyprexa/Zydis (olanzapine))
    Taking
    Item
    Was this atypical antipsychotic medication taken?
    boolean
    C1290952 (UMLS CUI [1,1])
    C1276996 (UMLS CUI [1,2])
    Date dose taken
    Item
    Date dose taken
    date
    C0011008 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1276996 (UMLS CUI [1,3])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1276996 (UMLS CUI [1,3])
    Item Group
    Investigational Product dosing
    C0304229 (UMLS CUI-1)
    C0678766 (UMLS CUI-2)
    Date dose taken
    Item
    Date dose taken
    date
    C0011008 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
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