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ID

29776

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 Screen Part 4: Psychiatric History and Evaluation, Medication.

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

    Screen Part 4: Psychiatric History and Examination, Medication

    1 forms  
    Psychiatric History
    Description

    Psychiatric History

    Alias
    UMLS CUI-1
    C0748059
    Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with Schizophrenia?
    Description

    Schizophrenia in first degree relative

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036341
    UMLS CUI [1,2]
    C1517194
    Which type of Schizophrenia DSM-IV diagnosis does the subject have?
    Description

    DSM-IV diagnosis: Schizophrenia type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036341
    UMLS CUI [1,2]
    C0220952
    Age (in whole years) of onset of psychotic symptoms
    Description

    Age of onset of psychotic symptoms

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1,1]
    C0150907
    UMLS CUI [1,2]
    C0871189
    years
    Subject is:
    Description

    Admission Type

    Data type

    text

    Alias
    UMLS CUI [1]
    C1550330
    Number of previous lifetime psychiatric hospitalizations
    Description

    Number of previous lifetime psychiatric hospitalizations

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0750480
    UMLS CUI [1,2]
    C0748061
    Has the subject ever attempted to commit suicide?
    Description

    Suicide attempt

    Data type

    text

    Alias
    UMLS CUI [1]
    C0038663
    Is the subject currently taking Abilify (aripiprazole, AB)?
    Description

    Aripiprazole

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0299792
    Is the subject currently taking Clozaril (clozapine, CL)?
    Description

    Clozapine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009079
    Is the subject currently taking Geodon (ziprasidone, GE)?
    Description

    Ziprasidone

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0380393
    Is the subject currently taking Risperdal (risperidone, RIS)?
    Description

    Risperidone

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0073393
    Is the subject currently taking Seroquel (quetiapine fumarate, SER)?
    Description

    Quetiapine fumarate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0123091
    Is the subject currently taking Zyprexa/Zydis (olanzapine, ZY)?
    Description

    Olanzapine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0171023
    Is the subject currently taking other antipsychotic medication?
    Description

    Other antipsychotics

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040615
    UMLS CUI [1,2]
    C0205394
    If subject is taking other antipsychotics, specify:
    Description

    Other Antipsychotics

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040615
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Prior Psychotropic Medication History
    Description

    Prior Psychotropic Medication History

    Alias
    UMLS CUI-1
    C0033978
    UMLS CUI-2
    C2826257
    Drug (Trade name preferred).
    Description

    Record over-the-counter and prescription drugs prescribed for CNS or psychiatric disorders.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Psychotropic Medication Dose
    Description

    Psychotropic Medication Dose

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0033978
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0033978
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3476109
    UMLS CUI [1,2]
    C0033978
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0033978
    Date Started
    Description

    Date started

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0033978
    Date Stopped
    Description

    If ongoing at baseline, record stop date as baseline visit date.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0033978
    Conditions Treated / Indication
    Description

    Conditions Treated / Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0033978
    Tolerance
    Description

    Tolerance

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0556444
    UMLS CUI [1,2]
    C0033978
    Response
    Description

    Response

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0033978
    Prior Non-psychotropic Medications
    Description

    Prior Non-psychotropic Medications

    Alias
    UMLS CUI-1
    C2826257
    Drug (Trade name preferred)
    Description

    Record all prior non-psychotropic medications (if ongoing at Baseline, record Stop Date as Baseline Visit Date, record medication on Concomitant Medication page with Start Date as Baseline Visit Date and check Started Pre-Study). Trade names are preferred for all medications; this is particularly encouraged for all combination medications, e.g., multivitamins and cold medications. The subject should be encouraged to disclose all medications he/she has taken, including non-prescribed medications, herbal remedies, and nutritional supplements. Record nonpsychotropic medications taken within the last month. Record over-the-counter and prescription drugs prescribed, excluding those for CNS or psychiatric disorders.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Dose
    Description

    Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C3174092
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C3174092
    Frequency
    Description

    Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Date started
    Description

    Date started

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0013227
    Date stopped
    Description

    All ongoing medications should be recorded on the CONCOMITANT MEDICATION page after the Baseline Visit. Use Date of the Baseline Visit as Date Stopped for this page.

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Conditions treated /Indication
    Description

    Conditions treated /Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Psychiatric Evaluation
    Description

    Psychiatric Evaluation

    Alias
    UMLS CUI-1
    C0846574
    Score of "Abnormal Involuntary Movement Scale" (AIMS)
    Description

    Abnormal Involuntary Movement Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0450978
    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

    Barnes Akathisia Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3541345
    Total Score of "Positive and Negative Syndrome Scale" (PANSS)
    Description

    Positive and Negative Syndrome Scale

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451383
    Score of "Clinicians Global Impressions - Severity" (CGI-S)
    Description

    Clinicians Global Impressions - Severity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3639708
    UMLS CUI [1,2]
    C3639887
    Pharmacokinetic Sampling
    Description

    Pharmacokinetic Sampling

    Alias
    UMLS CUI-1
    C0201734
    UMLS CUI-2
    C0005834
    Date of sampling
    Description

    Screening Sample number: BLD001

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0011008
    Actual Time of Sampling
    Description

    Time of Sampling

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0040223
    Was a blood sample for Pharmacokintetic studies taken?
    Description

    Sample Number at Screening: BLD001

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    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 marked the atypical antipsychotic medication taken?
    Description

    Intake of antipsychotic drug

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040615
    UMLS CUI [1,2]
    C1512806
    Date dose taken
    Description

    Date dose taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C1276996
    Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C1276996
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    Similar models

    Screen Part 4: Psychiatric History and Examination, Medication

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Psychiatric History
    C0748059 (UMLS CUI-1)
    Item
    Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with Schizophrenia?
    text
    C0036341 (UMLS CUI [1,1])
    C1517194 (UMLS CUI [1,2])
    Schizophrenia in first degree relative
    Code List
    Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with Schizophrenia?
    CL Item
    yes (Y)
    CL Item
    no (N)
    CL Item
    unknown (U)
    Item
    Which type of Schizophrenia DSM-IV diagnosis does the subject have?
    text
    C0036341 (UMLS CUI [1,1])
    C0220952 (UMLS CUI [1,2])
    DSM-IV diagnosis: Schizophrenia type
    Code List
    Which type of Schizophrenia DSM-IV diagnosis does the subject have?
    CL Item
    Schizophrenia Disorganized Type (295.10)
    CL Item
    Schizophrenia Catatonic Type (295.20)
    CL Item
    Schizophrenia Paranoid Type (295.30)
    CL Item
    Schizophrenia Undifferentiated Type (295.90)
    Age of onset of psychotic symptoms
    Item
    Age (in whole years) of onset of psychotic symptoms
    integer
    C0150907 (UMLS CUI [1,1])
    C0871189 (UMLS CUI [1,2])
    Item
    Subject is:
    text
    C1550330 (UMLS CUI [1])
    Admission Type
    Code List
    Subject is:
    CL Item
    outpatient (O)
    CL Item
    inpatient (I)
    Number of previous lifetime psychiatric hospitalizations
    Item
    Number of previous lifetime psychiatric hospitalizations
    integer
    C0750480 (UMLS CUI [1,1])
    C0748061 (UMLS CUI [1,2])
    Item
    Has the subject ever attempted to commit suicide?
    text
    C0038663 (UMLS CUI [1])
    Suicide attempt
    Code List
    Has the subject ever attempted to commit suicide?
    CL Item
    yes (Y)
    CL Item
    no (N)
    Aripiprazole
    Item
    Is the subject currently taking Abilify (aripiprazole, AB)?
    boolean
    C0299792 (UMLS CUI [1])
    Clozapine
    Item
    Is the subject currently taking Clozaril (clozapine, CL)?
    boolean
    C0009079 (UMLS CUI [1])
    Ziprasidone
    Item
    Is the subject currently taking Geodon (ziprasidone, GE)?
    boolean
    C0380393 (UMLS CUI [1])
    Risperidone
    Item
    Is the subject currently taking Risperdal (risperidone, RIS)?
    boolean
    C0073393 (UMLS CUI [1])
    Quetiapine fumarate
    Item
    Is the subject currently taking Seroquel (quetiapine fumarate, SER)?
    boolean
    C0123091 (UMLS CUI [1])
    Olanzapine
    Item
    Is the subject currently taking Zyprexa/Zydis (olanzapine, ZY)?
    boolean
    C0171023 (UMLS CUI [1])
    Other antipsychotics
    Item
    Is the subject currently taking other antipsychotic medication?
    boolean
    C0040615 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other Antipsychotics
    Item
    If subject is taking other antipsychotics, specify:
    text
    C0040615 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Prior Psychotropic Medication History
    C0033978 (UMLS CUI-1)
    C2826257 (UMLS CUI-2)
    Drug name
    Item
    Drug (Trade name preferred).
    text
    C2360065 (UMLS CUI [1])
    Psychotropic Medication Dose
    Item
    Psychotropic Medication Dose
    float
    C3174092 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0033978 (UMLS CUI [1,3])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Date started
    Item
    Date Started
    date
    C0808070 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Date Stopped
    Item
    Date Stopped
    date
    C0806020 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Conditions Treated / Indication
    Item
    Conditions Treated / Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Item
    Tolerance
    integer
    C0556444 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Tolerance
    Code List
    Tolerance
    CL Item
    good (1)
    CL Item
    fair (2)
    CL Item
    poor (3)
    Item
    Response
    integer
    C0521982 (UMLS CUI [1,1])
    C0033978 (UMLS CUI [1,2])
    Response
    Code List
    Response
    CL Item
    good (1)
    CL Item
    fair (2)
    CL Item
    poor (3)
    Item Group
    Prior Non-psychotropic Medications
    C2826257 (UMLS CUI-1)
    Drug name
    Item
    Drug (Trade name preferred)
    text
    C2360065 (UMLS CUI [1])
    Dose
    Item
    Dose
    float
    C3174092 (UMLS CUI [1])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Frequency
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Date started
    Item
    Date started
    date
    C0808070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Date stopped
    Item
    Date stopped
    date
    C0806020 (UMLS CUI [1])
    Conditions treated /Indication
    Item
    Conditions treated /Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item Group
    Psychiatric Evaluation
    C0846574 (UMLS CUI-1)
    Abnormal Involuntary Movement Scale
    Item
    Score of "Abnormal Involuntary Movement Scale" (AIMS)
    integer
    C0450978 (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])
    Barnes Akathisia Scale
    Item
    Score of "Barnes Akathisia Scale"
    integer
    C3541345 (UMLS CUI [1])
    Positive and Negative Syndrome Scale
    Item
    Total Score of "Positive and Negative Syndrome Scale" (PANSS)
    integer
    C0451383 (UMLS CUI [1])
    Clinicians Global Impressions - Severity
    Item
    Score of "Clinicians Global Impressions - Severity" (CGI-S)
    boolean
    C3639708 (UMLS CUI [1,1])
    C3639887 (UMLS CUI [1,2])
    Item Group
    Pharmacokinetic Sampling
    C0201734 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Date of Sampling
    Item
    Date of sampling
    date
    C0178913 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of Sampling
    Item
    Actual Time of Sampling
    time
    C0005834 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Pharmacokinetic blood sample
    Item
    Was a blood sample for Pharmacokintetic studies taken?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0031328 (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))
    Intake of antipsychotic drug
    Item
    Was marked the atypical antipsychotic medication taken?
    boolean
    C0040615 (UMLS CUI [1,1])
    C1512806 (UMLS CUI [1,2])
    Date dose taken
    Item
    Date dose taken
    date
    C0011008 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C1276996 (UMLS CUI [1,3])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1,1])
    C1276996 (UMLS CUI [1,2])
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