ID
44092
Beskrivning
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 12 - Visit 11 or Early Withdrawal.
Länk
https://clinicaltrials.gov/ct2/show/NCT00086593
Nyckelord
Versioner (2)
- 2018-04-19 2018-04-19 - Sarah Riepenhausen
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 september 2021
DOI
För en begäran logga in.
Licens
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
Week 12 - Visit 11 or Early Withdrawal
- StudyEvent: ODM
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Beskrivning
Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beskrivning
Systolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic Blood Pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Hair and skin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Beskrivning
Hair and Skin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
- UMLS CUI [1,3]
- C1704258
Beskrivning
Lymph nodes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Beskrivning
Lymph nodes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C1704258
Beskrivning
Eyes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Beskrivning
Eyes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
- UMLS CUI [1,3]
- C1704258
Beskrivning
Ears, Nose and Throat
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Beskrivning
Ears, Nose and Throat
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
- UMLS CUI [1,3]
- C1704258
Beskrivning
Breasts
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Beskrivning
Breasts
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C1704258
Beskrivning
Respiratory
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0436121
Beskrivning
Respiratory
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0436121
- UMLS CUI [1,3]
- C1704258
Beskrivning
Cardiovascular
Datatyp
text
Alias
- UMLS CUI [1]
- C3854344
Beskrivning
Cardiovascular
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3854344
- UMLS CUI [1,2]
- C1704258
Beskrivning
Abdomen
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beskrivning
Abdomen
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C1704258
Beskrivning
Urogenital
Datatyp
text
Alias
- UMLS CUI [1]
- C1828035
Beskrivning
Urogenital
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1828035
- UMLS CUI [1,2]
- C1704258
Beskrivning
Pelvic
Datatyp
text
Alias
- UMLS CUI [1]
- C0200045
Beskrivning
Pelvic
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0200045
- UMLS CUI [1,2]
- C1704258
Beskrivning
Rectal
Datatyp
text
Alias
- UMLS CUI [1]
- C0199900
Beskrivning
Rectal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199900
- UMLS CUI [1,2]
- C1704258
Beskrivning
Musculoskeletal
Datatyp
text
Alias
- UMLS CUI [1]
- C0475091
Beskrivning
Musculoskeletal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0475091
- UMLS CUI [1,2]
- C1704258
Beskrivning
Neurological
Datatyp
text
Alias
- UMLS CUI [1]
- C0027853
Beskrivning
Neurological
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beskrivning
Mental status
Datatyp
text
Alias
- UMLS CUI [1]
- C3260990
Beskrivning
Mental Status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3260990
- UMLS CUI [1,2]
- C1704258
Beskrivning
Psychiatric Evaluation
Alias
- UMLS CUI-1
- C0846574
Beskrivning
Positive and Negative Syndrome Scale (PANSS)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451383
Beskrivning
Positive and Negative Syndrome Scale (PANSS) - Positive Scale
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451383
Beskrivning
Positive and Negative Syndrome Scale (PANSS) - Negative Scale
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451383
Beskrivning
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451383
Beskrivning
5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4511599
- UMLS CUI [1,2]
- C0681889
- UMLS CUI [1,3]
- C0036341
Beskrivning
Calgary Depression Scale for Schizophrenia (CDSS)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0679604
- UMLS CUI [1,2]
- C0036341
Beskrivning
Clinicians Global Impressions - Severity (CGI-S)
Datatyp
integer
Alias
- UMLS CUI [1]
- C3639887
Beskrivning
Clinicians Global Impressions - Improvement (CGI-I)
Datatyp
integer
Alias
- UMLS CUI [1]
- C3639888
Beskrivning
Brief Assessment of Cognition for Schizophrenia (BACS)
Datatyp
integer
Alias
- UMLS CUI [1]
- C4055347
Beskrivning
Simpson Angus Scale
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0015371
Beskrivning
The Barnes Akathisia Scale
Datatyp
integer
Alias
- UMLS CUI [1]
- C3541345
Beskrivning
Abnormal Involuntary Movement Scale (AIMS)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0450978
Beskrivning
Pharmacokinetic Sampling
Beskrivning
Sample No.: BLD006
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0201734
Beskrivning
Sampling Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Beskrivning
Sample No.: BLD006
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201734
Beskrivning
Atypical Antipsychotic Dosing
Alias
- UMLS CUI-1
- C0040615
- UMLS CUI-2
- C0205182
- UMLS CUI-3
- C0178602
Beskrivning
Drug Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C1276996
Beskrivning
Taking
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1290952
- UMLS CUI [1,2]
- C1276996
Beskrivning
Date dose taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Beskrivning
Time dose taken
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Beskrivning
Quality of Life Assessment
Alias
- UMLS CUI-1
- C0034380
Beskrivning
Investigational Product Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
Similar models
Week 12 - Visit 11 or Early Withdrawal
- StudyEvent: ODM
C0518766 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0024204 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0200149 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0199850 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0436121 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C0036341 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C0205182 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C1276996 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1276996 (UMLS CUI [1,3])
C0678766 (UMLS CUI-2)
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])