ID
44099
Beschreibung
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
Stichworte
Versionen (3)
- 16.12.16 16.12.16 -
- 19.04.18 19.04.18 - Sarah Riepenhausen
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. September 2021
DOI
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Lizenz
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
Eligibility Criteria
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beschreibung
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Datentyp
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
Beschreibung
Axis I diagnosis predominant | Schizophrenia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0270287
- UMLS CUI [1,2]
- C1542147
- UMLS CUI [2]
- C0036341
Beschreibung
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
Datentyp
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
Beschreibung
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Datentyp
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
Beschreibung
Unique body areas are defined as face, lips or perioral area, jaw, tongue, upper extremities, lower extremities, and trunk.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0450978
- UMLS CUI [2,1]
- C0030569
- UMLS CUI [2,2]
- C0450973
- UMLS CUI [3]
- C3541345
Beschreibung
abnormal hematology, blood chemistry, ECG or physical examination
Datentyp
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
Beschreibung
Psychotropic Drugs | Central Nervous System Agents Primary
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033978
- UMLS CUI [2,1]
- C0007680
- UMLS CUI [2,2]
- C0205225
Beschreibung
Antidepressive Agents | Mood Stabilizer
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003289
- UMLS CUI [2]
- C2917435
Beschreibung
more than 2 atypical antipsychotics
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1276996
- UMLS CUI [1,2]
- C1265611
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038580
- UMLS CUI [2]
- C0743300
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0064636
- UMLS CUI [1,2]
- C1514463
Beschreibung
Psychotherapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033968
Beschreibung
Homicidal or suicidal risk
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0563664
- UMLS CUI [2,1]
- C0019872
- UMLS CUI [2,2]
- C1444641
Beschreibung
Pregnancy test, planning pregnancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0240802
- UMLS CUI [2,1]
- C0032961
- UMLS CUI [2,2]
- C1301732
Beschreibung
Investigational Medication within 30 days prior to screening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Ähnliche Modelle
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])