ID

23052

Description

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

Link

https://clinicaltrials.gov/show/NCT00322023

Keywords

Versions (1)
  1. 6/21/17 6/21/17 -
Uploaded on

June 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00322023

English

Eligibility Schizophrenia NCT00322023

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Schizophrenia | Schizoaffective Disorder

Data type

boolean

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

Positive and negative syndrome scale Factor Analysis

Data type

boolean

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

Positive and negative syndrome scale

Data type

boolean

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

Rating scale Parkinsonism

Data type

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
Description

Depression score | Suicide score

Data type

boolean

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

Clinical Global Impression Questionnaire unchanged

Data type

boolean

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

Chlorpromazine equivalent Dosage

Data type

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
Description

Sexually active Contraceptive methods

Data type

boolean

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

Exclusion Criteria

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

Extrapyramidal symptoms High

Data type

boolean

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

Psychotropic Drugs Started | Psychotropic Drugs Discontinued | Psychotropic Drugs Adjusted

Data type

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
Description

Investigational New Drugs

Data type

boolean

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

Medical contraindication Investigational New Drugs

Data type

boolean

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

Illness Serious | Illness Unstable

Data type

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
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Substance Use Disorders

Data type

boolean

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

Neurodegenerative Disorders | Epilepsy

Data type

boolean

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

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
currently taking clozapine
Description

Clozapine

Data type

boolean

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

Antipsychotic Agents Quantity

Data type

boolean

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

Stimulant | Cholinesterase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0304402
UMLS CUI [2]
C0008425
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Similar models

Eligibility Schizophrenia NCT00322023

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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