ID

19238

Description

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00063297

Link

https://clinicaltrials.gov/show/NCT00063297

Keywords

Versions (1)
  1. 12/14/16 12/14/16 -
Uploaded on

December 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00063297

English

Eligibility Schizophrenia NCT00063297

1 forms  
Criteria
Description

Criteria

adults aged 18-60
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
current diagnosis of schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
Description

Symptoms Negative Significant | Symptoms Positive Few | Hallucinations | Delusions | Major Depressive Disorder Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0205388
UMLS CUI [3]
C0018524
UMLS CUI [4]
C0011253
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C3887511
female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
subjects must be able to provide consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must be healthy based on medical exam, laboratory tests and electrocardiogram
Description

Healthy | Medical Examination | Laboratory Procedures | Electrocardiography

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0582103
UMLS CUI [3]
C0022885
UMLS CUI [4]
C1623258
exclusion:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
female subjects who are either pregnant or nursing.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
acute or unstable medical conditions
Description

Medical condition | Medical condition Unstable

Data type

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
diseases of the central nervous system
Description

CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682
subjects who are judged clinically to be at serious risk for suicide or violence
Description

At risk for suicide Serious | At risk for violence Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0231418
UMLS CUI [2,2]
C0205404
subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
Description

Delusional disorder | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Attention deficit hyperactivity disorder | Major Depressive Disorder | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0011251
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036358
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0005586
UMLS CUI [6]
C1263846
UMLS CUI [7]
C1269683
UMLS CUI [8]
C0038580
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Similar models

Eligibility Schizophrenia NCT00063297

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Age
Item
adults aged 18-60
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Schizophrenia
Item
current diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Symptoms Negative Significant | Symptoms Positive Few | Hallucinations | Delusions | Major Depressive Disorder Evidence
Item
significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
boolean
C1457887 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0205388 (UMLS CUI [2,3])
C0018524 (UMLS CUI [3])
C0011253 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C3887511 (UMLS CUI [5,2])
Childbearing Potential Pregnancy test negative
Item
female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
subjects must be able to provide consent
boolean
C0021430 (UMLS CUI [1])
Healthy | Medical Examination | Laboratory Procedures | Electrocardiography
Item
must be healthy based on medical exam, laboratory tests and electrocardiogram
boolean
C3898900 (UMLS CUI [1])
C0582103 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
Exclusion Criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female subjects who are either pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition | Medical condition Unstable
Item
acute or unstable medical conditions
boolean
C3843040 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
CNS disorder
Item
diseases of the central nervous system
boolean
C0007682 (UMLS CUI [1])
At risk for suicide Serious | At risk for violence Serious
Item
subjects who are judged clinically to be at serious risk for suicide or violence
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0231418 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Delusional disorder | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Bipolar Disorder | Attention deficit hyperactivity disorder | Major Depressive Disorder | Substance Dependence
Item
subjects with delusional disorder, psychotic disorder nos, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
boolean
C0011251 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C1263846 (UMLS CUI [6])
C1269683 (UMLS CUI [7])
C0038580 (UMLS CUI [8])
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