ID
29788
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 12 - Visit 11 or Early Withdrawal.
Lien
https://clinicaltrials.gov/ct2/show/NCT00086593
Mots-clés
Versions (2)
- 19/04/2018 19/04/2018 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
19 avril 2018
DOI
Pour une demande vous connecter.
Licence
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
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
If assessments are taken on 2 separate dates for this visit, the Visit Date is the first date the subject is seen.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Description
Record both; record sitting heart rate and blood pressure prior to recording standing heart rate and blood pressure.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Hair and skin
Type de données
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
Description
Hair and Skin
Type de données
text
Alias
- UMLS CUI [1,1]
- C0018494
- UMLS CUI [1,2]
- C0558035
- UMLS CUI [1,3]
- C1704258
Description
Lymph nodes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
Description
Lymph nodes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024204
- UMLS CUI [1,3]
- C1704258
Description
Eyes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
Description
Eyes
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0200149
- UMLS CUI [1,3]
- C1704258
Description
Ears, Nose and Throat
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
Description
Ears, Nose and Throat
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0278350
- UMLS CUI [1,3]
- C1704258
Description
Breasts
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
Description
Breasts
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0199850
- UMLS CUI [1,3]
- C1704258
Description
Respiratory
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
Description
Respiratory
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0599324
- UMLS CUI [1,3]
- C1704258
Description
Cardiovascular
Type de données
text
Alias
- UMLS CUI [1]
- C3854344
Description
Cardiovascular
Type de données
text
Alias
- UMLS CUI [1,1]
- C3854344
- UMLS CUI [1,2]
- C1704258
Description
Abdomen
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
Abdomen
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
- UMLS CUI [1,3]
- C1704258
Description
Urogenital
Type de données
text
Alias
- UMLS CUI [1]
- C1828035
Description
Urogenital
Type de données
text
Alias
- UMLS CUI [1,1]
- C1828035
- UMLS CUI [1,2]
- C1704258
Description
Pelvic
Type de données
text
Alias
- UMLS CUI [1]
- C0200045
Description
Pelvic
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200045
- UMLS CUI [1,2]
- C1704258
Description
Rectal
Type de données
text
Alias
- UMLS CUI [1]
- C0199900
Description
Rectal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0199900
- UMLS CUI [1,2]
- C1704258
Description
Musculoskeletal
Type de données
text
Alias
- UMLS CUI [1]
- C0475091
Description
Musculoskeletal
Type de données
text
Alias
- UMLS CUI [1,1]
- C0475091
- UMLS CUI [1,2]
- C1704258
Description
Neurological
Type de données
text
Alias
- UMLS CUI [1]
- C0027853
Description
Neurological
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Description
Mental status
Type de données
text
Alias
- UMLS CUI [1]
- C3260990
Description
Mental Status
Type de données
text
Alias
- UMLS CUI [1,1]
- C3260990
- UMLS CUI [1,2]
- C1704258
Description
Psychiatric Evaluation
Alias
- UMLS CUI-1
- C0846574
Description
Positive and Negative Syndrome Scale (PANSS)
Type de données
integer
Alias
- UMLS CUI [1]
- C0451383
Description
Positive and Negative Syndrome Scale (PANSS) - Positive Scale
Type de données
integer
Alias
- UMLS CUI [1]
- C0451383
Description
Positive and Negative Syndrome Scale (PANSS) - Negative Scale
Type de données
integer
Alias
- UMLS CUI [1]
- C0451383
Description
Positive and Negative Syndrome Scale (PANSS) - General Psychopathology
Type de données
integer
Alias
- UMLS CUI [1]
- C0451383
Description
5 Subdomains: Affective Flattening or Blunting Alogia Avolition - Apathy Anhedonia - Asociality Attention
Type de données
integer
Alias
- UMLS CUI [1,1]
- C4511599
- UMLS CUI [1,2]
- C0681889
- UMLS CUI [1,3]
- C0036341
Description
Calgary Depression Scale for Schizophrenia (CDSS)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0679604
- UMLS CUI [1,2]
- C0036341
Description
Clinicians Global Impressions - Severity (CGI-S)
Type de données
integer
Alias
- UMLS CUI [1]
- C3639887
Description
Clinicians Global Impressions - Improvement (CGI-I)
Type de données
integer
Alias
- UMLS CUI [1]
- C3639888
Description
Brief Assessment of Cognition for Schizophrenia (BACS)
Type de données
integer
Alias
- UMLS CUI [1]
- C4055347
Description
Simpson Angus Scale
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0681889
- UMLS CUI [1,2]
- C0041755
- UMLS CUI [1,3]
- C0015371
Description
The Barnes Akathisia Scale
Type de données
integer
Alias
- UMLS CUI [1]
- C3541345
Description
Abnormal Involuntary Movement Scale (AIMS)
Type de données
integer
Alias
- UMLS CUI [1]
- C0450978
Description
Pharmacokinetic Sampling
Description
Sample No.: BLD006
Type de données
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0201734
Description
Sampling Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0201734
Description
Sample No.: BLD006
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201734
Description
Atypical Antipsychotic Dosing
Alias
- UMLS CUI-1
- C0040615
- UMLS CUI-2
- C0205182
- UMLS CUI-3
- C0178602
Description
Drug Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C1276996
Description
Taking
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1290952
- UMLS CUI [1,2]
- C1276996
Description
Date dose taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Description
Time dose taken
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1276996
Description
Quality of Life Assessment
Alias
- UMLS CUI-1
- C0034380
Description
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])
C0599324 (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])