0 Ratings
ID

29787

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 10 - Visit 10.

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

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593

    English

    Week 10 - Visit 10

    1 forms  
    1. StudyEvent: ODM
      1. Week 10 - Visit 10
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    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 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    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 (Body position)
    SNOMED
    397155001
    LOINC
    LP120681-4
    UMLS CUI [1,2]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Psychiatric Evaluation
    Description

    Psychiatric Evaluation

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

    Positive and Negative Syndrome Scale (PANSS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451383 (Positive and negative syndrome scale)
    SNOMED
    273703003
    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 (Negative symptoms co-occurrent and due to primary psychotic disorder)
    SNOMED
    724756001
    UMLS CUI [1,2]
    C0681889 (rating scale)
    UMLS CUI [1,3]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    Score of "Calgary Depression Scale for Schizophrenia"
    Description

    Calgary Depression Scale for Schizophrenia (CDSS)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0679604 (depression scale)
    UMLS CUI [1,2]
    C0036341 (Schizophrenia)
    SNOMED
    58214004
    LOINC
    MTHU020814
    Score of Clinicians Global Impressions, Part Severity (CGI-S)
    Description

    Clinicians Global Impressions - Severity (CGI-S)

    Data type

    integer

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

    Clinicians Global Impressions - Improvement (CGI-I)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3639888 (CGI - Global Improvement)
    Score of "Brief Assessment of Cognition for Schizophrenia"
    Description

    Brief Assessment of Cognition for Schizophrenia (BACS)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C4055347 (Brief Assessment of Cognition in Schizophrenia Functional Test)
    Pharmacokinetic Sampling
    Description

    Pharmacokinetic Sampling

    Sampling Date
    Description

    Sample No.: BLD005

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Sampling TIme
    Description

    Sampling Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Blood Sample taken?
    Description

    Sample No.: BLD005

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    Atypical Antipsychotic Dosing
    Description

    Atypical Antipsychotic Dosing

    Alias
    UMLS CUI-1
    C0040615 (Antipsychotic Agents)
    SNOMED
    10784006
    LOINC
    LP18073-4
    UMLS CUI-2
    C0205182 (Atypical)
    SNOMED
    112231000
    LOINC
    LA13702-8
    UMLS CUI-3
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Drug Name
    Description

    Drug Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    UMLS CUI [1,2]
    C1276996 (Atypical antipsychotic)
    Was this atypical antipsychotic medication taken?
    Description

    Taking

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1290952 (Taking medication (activity))
    SNOMED
    129019007
    UMLS CUI [1,2]
    C1276996 (Atypical antipsychotic)
    Date dose taken
    Description

    Date dose taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1276996 (Atypical antipsychotic)
    Time dose taken
    Description

    Time dose taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C1276996 (Atypical antipsychotic)
    Investigational Product Dosing
    Description

    Investigational Product Dosing

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0678766 (Drug dose)
    SNOMED
    398232005
    Date dose taken
    Description

    Planned relative Time: Day before Clinic Visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Time dose taken
    Description

    Time dose taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Back to the top of the page

    Similar models

    Week 10 - Visit 10

    1 forms
    1. StudyEvent: ODM
      1. Week 10 - Visit 10
    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])
    Brief Assessment of Cognition for Schizophrenia (BACS)
    Item
    Score of "Brief Assessment of Cognition for Schizophrenia"
    integer
    C4055347 (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])
    C0013227 (UMLS CUI [1,2])
    Time dose taken
    Item
    Time dose taken
    time
    C0040223 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial