ID

23052

Beskrivning

Safety and Effectiveness of D-Serine in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00322023

Länk

https://clinicaltrials.gov/show/NCT00322023

Nyckelord

Versioner (1)
  1. 2017-06-21 2017-06-21 -
Uppladdad den

21 juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00322023

Engelsk

Eligibility Schizophrenia NCT00322023

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
structured clinical interview for dsm-iii-r diagnosis of schizophrenia or schizoaffective disorder
Beskrivning

Schizophrenia | Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
panss 3 factor negative symptom inclusion score greater than 20 prior to study entry
Beskrivning

Positive and negative syndrome scale Factor Analysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0085801
panss total score between 60 and 110
Beskrivning

Positive and negative syndrome scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451383
simpson-angus scale total score of 12 or less
Beskrivning

Rating scale Parkinsonism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0242422
calgary depression inventory total score of 10 and suicide score less than 2
Beskrivning

Depression score | Suicide score

Datatyp

boolean

Alias
UMLS CUI [1]
C3483981
UMLS CUI [2]
C0560334
no change in clinical global impressions (cgi) scale score prior to study entry
Beskrivning

Clinical Global Impression Questionnaire unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C0442739
chlorpromazine (cpz) equivalent of 1500 or less
Beskrivning

Chlorpromazine equivalent Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008286
UMLS CUI [1,2]
C3242703
UMLS CUI [1,3]
C0178602
willing to use an effective form of birth control throughout the study if sexually active
Beskrivning

Sexually active Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
high extrapyramidal symptom (eps) levels
Beskrivning

Extrapyramidal symptoms High

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0234133
UMLS CUI [1,2]
C0205250
began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
Beskrivning

Psychotropic Drugs Started | Psychotropic Drugs Discontinued | Psychotropic Drugs Adjusted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C1272689
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0033978
UMLS CUI [3,2]
C0456081
taking investigational medication within 2 weeks of study entry
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
contraindication to study medication
Beskrivning

Medical contraindication Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
serious or unstable medical illness
Beskrivning

Illness Serious | Illness Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0443343
pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol or drug abuse within 6 months of study entry
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
diagnosed with neurodegenerative disease or a seizure disorder
Beskrivning

Neurodegenerative Disorders | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0524851
UMLS CUI [2]
C0014544
history of a kidney impairment
Beskrivning

Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
currently taking clozapine
Beskrivning

Clozapine

Datatyp

boolean

Alias
UMLS CUI [1]
C0009079
currently taking more than two antipsychotic medications
Beskrivning

Antipsychotic Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
currently taking stimulants or cholinesterase inhibitors
Beskrivning

Stimulant | Cholinesterase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0304402
UMLS CUI [2]
C0008425
Tillbaka till toppen

Similar models

Eligibility Schizophrenia NCT00322023

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Schizoaffective Disorder
Item
structured clinical interview for dsm-iii-r diagnosis of schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Positive and negative syndrome scale Factor Analysis
Item
panss 3 factor negative symptom inclusion score greater than 20 prior to study entry
boolean
C0451383 (UMLS CUI [1,1])
C0085801 (UMLS CUI [1,2])
Positive and negative syndrome scale
Item
panss total score between 60 and 110
boolean
C0451383 (UMLS CUI [1])
Rating scale Parkinsonism
Item
simpson-angus scale total score of 12 or less
boolean
C0681889 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
Depression score | Suicide score
Item
calgary depression inventory total score of 10 and suicide score less than 2
boolean
C3483981 (UMLS CUI [1])
C0560334 (UMLS CUI [2])
Clinical Global Impression Questionnaire unchanged
Item
no change in clinical global impressions (cgi) scale score prior to study entry
boolean
C3639708 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
Chlorpromazine equivalent Dosage
Item
chlorpromazine (cpz) equivalent of 1500 or less
boolean
C0008286 (UMLS CUI [1,1])
C3242703 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Sexually active Contraceptive methods
Item
willing to use an effective form of birth control throughout the study if sexually active
boolean
C0241028 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Extrapyramidal symptoms High
Item
high extrapyramidal symptom (eps) levels
boolean
C0234133 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Psychotropic Drugs Started | Psychotropic Drugs Discontinued | Psychotropic Drugs Adjusted
Item
began, discontinued, or adjusted psychotropic medication within 2 weeks of study entry
boolean
C0033978 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0033978 (UMLS CUI [3,1])
C0456081 (UMLS CUI [3,2])
Investigational New Drugs
Item
taking investigational medication within 2 weeks of study entry
boolean
C0013230 (UMLS CUI [1])
Medical contraindication Investigational New Drugs
Item
contraindication to study medication
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Illness Serious | Illness Unstable
Item
serious or unstable medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse within 6 months of study entry
boolean
C0038586 (UMLS CUI [1])
Neurodegenerative Disorders | Epilepsy
Item
diagnosed with neurodegenerative disease or a seizure disorder
boolean
C0524851 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Renal Insufficiency
Item
history of a kidney impairment
boolean
C1565489 (UMLS CUI [1])
Clozapine
Item
currently taking clozapine
boolean
C0009079 (UMLS CUI [1])
Antipsychotic Agents Quantity
Item
currently taking more than two antipsychotic medications
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Stimulant | Cholinesterase Inhibitors
Item
currently taking stimulants or cholinesterase inhibitors
boolean
C0304402 (UMLS CUI [1])
C0008425 (UMLS CUI [2])
Tillbaka till toppen 

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