ID
44099
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 Eligibility Criteria.
Länk
https://clinicaltrials.gov/ct2/show/NCT00086593
Nyckelord
Versioner (3)
- 2016-12-16 2016-12-16 -
- 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
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593
Eligibility Criteria
- StudyEvent: Eligibility
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beskrivning
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Datatyp
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
Beskrivning
Axis I diagnosis predominant | Schizophrenia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0270287
- UMLS CUI [1,2]
- C1542147
- UMLS CUI [2]
- C0036341
Beskrivning
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
Datatyp
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
Beskrivning
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Datatyp
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
Beskrivning
Unique body areas are defined as face, lips or perioral area, jaw, tongue, upper extremities, lower extremities, and trunk.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0450978
- UMLS CUI [2,1]
- C0030569
- UMLS CUI [2,2]
- C0450973
- UMLS CUI [3]
- C3541345
Beskrivning
abnormal hematology, blood chemistry, ECG or physical examination
Datatyp
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
Beskrivning
Psychotropic Drugs | Central Nervous System Agents Primary
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2,1]
- C0007680
- UMLS CUI [2,2]
- C0205225
Beskrivning
Antidepressive Agents | Mood Stabilizer
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0003289
- UMLS CUI [2]
- C2917435
Beskrivning
more than 2 atypical antipsychotics
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1276996
- UMLS CUI [1,2]
- C1265611
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038580
- UMLS CUI [2]
- C0743300
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0064636
- UMLS CUI [1,2]
- C1514463
Beskrivning
Psychotherapy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033968
Beskrivning
Homicidal or suicidal risk
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0563664
- UMLS CUI [2,1]
- C0019872
- UMLS CUI [2,2]
- C1444641
Beskrivning
Pregnancy test, planning pregnancy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0240802
- UMLS CUI [2,1]
- C0032961
- UMLS CUI [2,2]
- C1301732
Beskrivning
Investigational Medication within 30 days prior to screening
Datatyp
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])