ID
44099
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 Eligibility Criteria.
Link
https://clinicaltrials.gov/ct2/show/NCT00086593
Keywords
Versions (3)
- 12/16/16 12/16/16 -
- 4/19/18 4/19/18 - Sarah Riepenhausen
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593
Eligibility Criteria
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Description
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0451383
- UMLS CUI [1,2]
- C0442805
- UMLS CUI [1,3]
- C0439165
- UMLS CUI [2,1]
- C0451383
- UMLS CUI [2,2]
- C0547047
- UMLS CUI [2,3]
- C0439165
Description
Axis I diagnosis predominant | Schizophrenia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0270287
- UMLS CUI [1,2]
- C1542147
- UMLS CUI [2]
- C0036341
Description
Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [1,3]
- C0521102
- UMLS CUI [1,4]
- C0008976
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C0443343
- UMLS CUI [2,3]
- C0521102
- UMLS CUI [2,4]
- C0008976
- UMLS CUI [3,1]
- C0087111
- UMLS CUI [3,2]
- C2826293
- UMLS CUI [3,3]
- C0521102
- UMLS CUI [3,4]
- C0008976
- UMLS CUI [4,1]
- C0087111
- UMLS CUI [4,2]
- C0443343
- UMLS CUI [4,3]
- C0521102
- UMLS CUI [4,4]
- C0008976
Description
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Data type
boolean
Alias
- UMLS CUI [1]
- C0004352
- UMLS CUI [2]
- C0524528
- UMLS CUI [3]
- C4062280
- UMLS CUI [4]
- C0497327
- UMLS CUI [5]
- C0038454
- UMLS CUI [6]
- C0014544
- UMLS CUI [7,1]
- C0036572
- UMLS CUI [7,2]
- C1514873
- UMLS CUI [7,3]
- C0087111
- UMLS CUI [8]
- C0009952
- UMLS CUI [9]
- C0018674
Description
Unique body areas are defined as face, lips or perioral area, jaw, tongue, upper extremities, lower extremities, and trunk.
Data type
boolean
Alias
- UMLS CUI [1]
- C0450978
- UMLS CUI [2,1]
- C0030569
- UMLS CUI [2,2]
- C0450973
- UMLS CUI [3]
- C3541345
Description
abnormal hematology, blood chemistry, ECG or physical examination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1332129
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2,1]
- C1623258
- UMLS CUI [2,2]
- C0205161
- UMLS CUI [3,1]
- C0031809
- UMLS CUI [3,2]
- C0205161
Description
Psychotropic Drugs | Central Nervous System Agents Primary
Data type
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2,1]
- C0007680
- UMLS CUI [2,2]
- C0205225
Description
Antidepressive Agents | Mood Stabilizer
Data type
boolean
Alias
- UMLS CUI [1]
- C0003289
- UMLS CUI [2]
- C2917435
Description
more than 2 atypical antipsychotics
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1276996
- UMLS CUI [1,2]
- C1265611
Description
Subjects who tested positive for cannabinoids on the Screening urine toxicology screen test will be permitted to be randomized and continue in the study provided that in the opinion of the Investigator, the positive test outcome resulted from incidental use of the identified substance in a circumstance not associated with dependence as described in the DSM-IV-TR and which did not interfere with psychometric testing.
Data type
boolean
Alias
- UMLS CUI [1]
- C0038580
- UMLS CUI [2]
- C0743300
Description
treatment was within six months of enrollment. treatment was six or more weeks in duration. treatment resulted in intolerance. treatment resulted in an allergic or idiosyncratic reaction, including rash. treatment was administered during a clinical study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0064636
- UMLS CUI [1,2]
- C1514463
Description
Psychotherapy
Data type
boolean
Alias
- UMLS CUI [1]
- C0033968
Description
Homicidal or suicidal risk
Data type
boolean
Alias
- UMLS CUI [1]
- C0563664
- UMLS CUI [2,1]
- C0019872
- UMLS CUI [2,2]
- C1444641
Description
Pregnancy test, planning pregnancy
Data type
boolean
Alias
- UMLS CUI [1]
- C0240802
- UMLS CUI [2,1]
- C0032961
- UMLS CUI [2,2]
- C1301732
Description
Investigational Medication within 30 days prior to screening
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Similar models
Eligibility Criteria
- StudyEvent: Eligibility
C0220952 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0086287 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C0442805 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C1542147 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0087111 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
C0524528 (UMLS CUI [2])
C4062280 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0009952 (UMLS CUI [8])
C0018674 (UMLS CUI [9])
C0030569 (UMLS CUI [2,1])
C0450973 (UMLS CUI [2,2])
C3541345 (UMLS CUI [3])
C0205161 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0007680 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2917435 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C0743300 (UMLS CUI [2])
C1514463 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])