ID

29776

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.04.18 19.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

19. April 2018

DOI

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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

Englisch

Screen Part 4: Psychiatric History and Examination, Medication

1 Formulare  
Psychiatric History
Beschreibung

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?
Beschreibung

Schizophrenia in first degree relative

Datentyp

text

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

DSM-IV diagnosis: Schizophrenia type

Datentyp

text

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

Age of onset of psychotic symptoms

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0150907
UMLS CUI [1,2]
C0871189
years
Subject is:
Beschreibung

Admission Type

Datentyp

text

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

Number of previous lifetime psychiatric hospitalizations

Datentyp

integer

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

Suicide attempt

Datentyp

text

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

Aripiprazole

Datentyp

boolean

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

Clozapine

Datentyp

boolean

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

Ziprasidone

Datentyp

boolean

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

Risperidone

Datentyp

boolean

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

Quetiapine fumarate

Datentyp

boolean

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

Olanzapine

Datentyp

boolean

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

Other antipsychotics

Datentyp

boolean

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

Other Antipsychotics

Datentyp

text

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

Prior Psychotropic Medication History

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

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

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Psychotropic Medication Dose
Beschreibung

Psychotropic Medication Dose

Datentyp

float

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

Units

Datentyp

text

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

Frequency

Datentyp

text

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

Route

Datentyp

text

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

Date started

Datentyp

date

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

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

Datentyp

date

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

Conditions Treated / Indication

Datentyp

text

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

Tolerance

Datentyp

integer

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

Response

Datentyp

integer

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

Prior Non-psychotropic Medications

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

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.

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Dose
Beschreibung

Dose

Datentyp

float

Alias
UMLS CUI [1]
C3174092
Units
Beschreibung

Units

Datentyp

text

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

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Date started
Beschreibung

Date started

Datentyp

date

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

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.

Datentyp

date

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

Conditions treated /Indication

Datentyp

text

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

Psychiatric Evaluation

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

Abnormal Involuntary Movement Scale

Datentyp

integer

Alias
UMLS CUI [1]
C0450978
Score of "Simpson Angus Scale"
Beschreibung

Simpson Angus Scale

Datentyp

integer

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

Barnes Akathisia Scale

Datentyp

integer

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

Positive and Negative Syndrome Scale

Datentyp

integer

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

Clinicians Global Impressions - Severity

Datentyp

boolean

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

Pharmacokinetic Sampling

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

Screening Sample number: BLD001

Datentyp

date

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

Time of Sampling

Datentyp

time

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

Sample Number at Screening: BLD001

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
Atypical Antipsychotic dosing
Beschreibung

Atypical Antipsychotic dosing

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

Drug Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C1276996
Was marked the atypical antipsychotic medication taken?
Beschreibung

Intake of antipsychotic drug

Datentyp

boolean

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

Date dose taken

Datentyp

date

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

Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1276996
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Ähnliche Modelle

Screen Part 4: Psychiatric History and Examination, Medication

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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