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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