ID

22746

Description

A Study of the Effects of Sarcosine on Symptoms and Brain Glycine Levels in People With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00538070

Link

https://clinicaltrials.gov/show/NCT00538070

Keywords

Versions (1)
  1. 6/11/17 6/11/17 -
Uploaded on

June 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00538070

English

Eligibility Schizophrenia NCT00538070

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women and men aged 18-65 with dsm-iv diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review.
Description

gender, age, dsm-iv diagnosis of schizophrenia or schizoaffective disorder

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C0220952
UMLS CUI [4,1]
C0036337
UMLS CUI [4,2]
C0220952
2. clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation.
Description

stable disease, stable dose of antipsychotic medication, no current active suicidal ideation

Data type

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0678766
UMLS CUI [3]
C0749133
3. competent to provide informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. women of childbearing age must have a negative pregnancy test at screening and agree to use an approved form of contraception throughout the study.
Description

childbearing age, pregnancy test, contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0032976
5. screening labs within normal limits for age and gender except for liver function tests as specified below.
Description

laboratory results normal for age and gender

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0586624
UMLS CUI [1,3]
C0079399
UMLS CUI [1,4]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis of bipolar disorder, dementia, neurodegenerative disease, or other organic mental disorder.
Description

bipolar disorder, dementia, neurodegenerative disease, organic mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0524851
UMLS CUI [4]
C0349095
2. history of seizure disorder or cns tumor.
Description

epilepsy, cns tumor

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0085136
3. liver function tests elevated over twice normal.
Description

liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
4. bulimia, or major depressive disorder within the last 6 months.
Description

bulimia, major depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0006370
UMLS CUI [2]
C1269683
5. life-threatening arrhythmia, cerebro-vascular, or cardiovascular event within 6 months. current serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months. lifetime history of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
Description

arrhythmia, cerebro-vascular or cardiovascular event, serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0038454
UMLS CUI [3]
C1320716
UMLS CUI [4,1]
C0443343
UMLS CUI [4,2]
C0018799
UMLS CUI [5,1]
C0443343
UMLS CUI [5,2]
C0023895
UMLS CUI [6,1]
C0443343
UMLS CUI [6,2]
C0024115
UMLS CUI [7,1]
C0443343
UMLS CUI [7,2]
C0014130
UMLS CUI [8,1]
C0443343
UMLS CUI [8,2]
C0027765
UMLS CUI [9,1]
C0443343
UMLS CUI [9,2]
C0018939
UMLS CUI [10,1]
C0451948
UMLS CUI [10,2]
C0496161
UMLS CUI [11,1]
C1282312
UMLS CUI [11,2]
C0496161
6. use of investigational medication within 30 days of enrollment.
Description

investigational medication

Data type

boolean

Alias
UMLS CUI [1]
C0013230
7. use of clozapine.
Description

clozapine

Data type

boolean

Alias
UMLS CUI [1]
C0009079
8. substance use disorder other than nicotine or caffeine in the last 6 months (by self report and salivary drug and alcohol screen).
Description

substance use disorder other than nicotine or caffeine

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0543414
UMLS CUI [3]
C2006086
9. posing a current risk of homicide or suicide.
Description

current risk of homicide or suicide

Data type

boolean

Alias
UMLS CUI [1]
C1948151
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Similar models

Eligibility Schizophrenia NCT00538070

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender, age, dsm-iv diagnosis of schizophrenia or schizoaffective disorder
Item
1. women and men aged 18-65 with dsm-iv diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0036341 (UMLS CUI [3,1])
C0220952 (UMLS CUI [3,2])
C0036337 (UMLS CUI [4,1])
C0220952 (UMLS CUI [4,2])
stable disease, stable dose of antipsychotic medication, no current active suicidal ideation
Item
2. clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation.
boolean
C0677946 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0749133 (UMLS CUI [3])
informed consent
Item
3. competent to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
childbearing age, pregnancy test, contraception
Item
4. women of childbearing age must have a negative pregnancy test at screening and agree to use an approved form of contraception throughout the study.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
laboratory results normal for age and gender
Item
5. screening labs within normal limits for age and gender except for liver function tests as specified below.
boolean
C1254595 (UMLS CUI [1,1])
C0586624 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
bipolar disorder, dementia, neurodegenerative disease, organic mental disorder
Item
1. diagnosis of bipolar disorder, dementia, neurodegenerative disease, or other organic mental disorder.
boolean
C0005586 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0524851 (UMLS CUI [3])
C0349095 (UMLS CUI [4])
epilepsy, cns tumor
Item
2. history of seizure disorder or cns tumor.
boolean
C0014544 (UMLS CUI [1])
C0085136 (UMLS CUI [2])
liver function
Item
3. liver function tests elevated over twice normal.
boolean
C0232741 (UMLS CUI [1])
bulimia, major depressive disorder
Item
4. bulimia, or major depressive disorder within the last 6 months.
boolean
C0006370 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
arrhythmia, cerebro-vascular or cardiovascular event, serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae
Item
5. life-threatening arrhythmia, cerebro-vascular, or cardiovascular event within 6 months. current serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months. lifetime history of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
boolean
C0003811 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C1320716 (UMLS CUI [3])
C0443343 (UMLS CUI [4,1])
C0018799 (UMLS CUI [4,2])
C0443343 (UMLS CUI [5,1])
C0023895 (UMLS CUI [5,2])
C0443343 (UMLS CUI [6,1])
C0024115 (UMLS CUI [6,2])
C0443343 (UMLS CUI [7,1])
C0014130 (UMLS CUI [7,2])
C0443343 (UMLS CUI [8,1])
C0027765 (UMLS CUI [8,2])
C0443343 (UMLS CUI [9,1])
C0018939 (UMLS CUI [9,2])
C0451948 (UMLS CUI [10,1])
C0496161 (UMLS CUI [10,2])
C1282312 (UMLS CUI [11,1])
C0496161 (UMLS CUI [11,2])
investigational medication
Item
6. use of investigational medication within 30 days of enrollment.
boolean
C0013230 (UMLS CUI [1])
clozapine
Item
7. use of clozapine.
boolean
C0009079 (UMLS CUI [1])
substance use disorder other than nicotine or caffeine
Item
8. substance use disorder other than nicotine or caffeine in the last 6 months (by self report and salivary drug and alcohol screen).
boolean
C0038586 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C2006086 (UMLS CUI [3])
current risk of homicide or suicide
Item
9. posing a current risk of homicide or suicide.
boolean
C1948151 (UMLS CUI [1])
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