ID

22274

Description

Neuroimaging Studies of Neurophysiological Phenotypes in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01036568

Link

https://clinicaltrials.gov/show/NCT01036568

Keywords

Versions (1)
  1. 5/28/17 5/28/17 -
Uploaded on

May 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01036568

English

Eligibility Schizophrenia NCT01036568

1 forms  
Criteria
Description

Criteria

all subjects:
Description

study subject

Data type

boolean

Alias
UMLS CUI [1]
C0681850
1. must be 18-62 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. must be in good general health based on medical history and physical examination.
Description

good general health

Data type

boolean

Alias
UMLS CUI [1]
C0424575
schizophrenic patients:
Description

schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
1. must have a dsm-iv diagnosis of schizophrenia.
Description

dsm-iv schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0220952
2. must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to the mri scan.
Description

clinically stable schizophrenia, medication change

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0580105
relatives of patients:
Description

patient relatives

Data type

boolean

Alias
UMLS CUI [1]
C0080103
1. must be first degree relatives (full sibling, parent, or offspring)
Description

first degree relatives

Data type

boolean

Alias
UMLS CUI [1]
C1517194
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
all subjects:
Description

study subject

Data type

boolean

Alias
UMLS CUI [1]
C0681850
1. individuals who have alcohol and/or marijuana dependence
Description

alcohol or cannabis dependence

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0006870
2. individuals who are pregnant; urine pregnancy tests will be performed on all female volunteers of childbearing potential before each experimental session.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
3. individuals who are unable to undergo mri scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
Description

mri contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
4. individuals who have major medical illnesses that may affect normal brain functioning or safety lying in the scanner. examples of these conditions include, but not limited to, stroke, seizure, hiv/aids, uncontrolled high blood pressure, history of significant head trauma, cns infection or tumor based on medical history, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
5. individuals who partake in significant alcohol or other drug use, other than nicotine dependence. significant drug use is defined as a history of alcohol or other substance dependence in the past 6 months or current substance abuse, with the following few exceptions. subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence.
Description

substance use disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
6. individuals with significant ophthalmological and/or neurological conditions who have severe vision impairments such that they cannot follow a moving dot 60 cm in front of them are excluded. participants with reduced vision are included as long as they can follow a moving dot 60 cm in front of them.
Description

ophthalmological or neurological disorder

Data type

boolean

Alias
UMLS CUI [1]
C0015397
UMLS CUI [2]
C0027765
healthy controls:
Description

healthy controls

Data type

boolean

Alias
UMLS CUI [1]
C2986479
1. individuals with psychiatric illness. the scid and structured interview for dsm-iv personality diagnoses (sidp) will be used to exclude volunteers with axis i and ii disorders.
Description

psychiatric illness, dsm-iv

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0220952
2. individuals with a family history of psychotic illness according to family history research diagnostic criteria (fh-rdc).
Description

family history of psychotic illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C1860474
UMLS CUI [1,3]
C0871251
first degree relatives of patients:
Description

first degree relatives

Data type

boolean

Alias
UMLS CUI [1]
C1517194
1. first degree relatives with a dsm-iv axis i diagnosis of psychosis, with the exception that a relative with a past history of psychosis will be included if symptoms are not present, and he/she is not taking antipsychotic drugs.
Description

first degree relatives psychosis

Data type

boolean

Alias
UMLS CUI [1]
C1517194
2. first degree relatives that meet sidp criteria for an axis ii disorder with exceptions made for relatives meeting criteria for schizophrenia spectrum personality disorders (sspd).
Description

axis ii disorder

Data type

boolean

Alias
UMLS CUI [1]
C0741358
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Similar models

Eligibility Schizophrenia NCT01036568

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
study subject
Item
all subjects:
boolean
C0681850 (UMLS CUI [1])
age
Item
1. must be 18-62 years of age.
boolean
C0001779 (UMLS CUI [1])
good general health
Item
2. must be in good general health based on medical history and physical examination.
boolean
C0424575 (UMLS CUI [1])
schizophrenia
Item
schizophrenic patients:
boolean
C0036341 (UMLS CUI [1])
dsm-iv schizophrenia
Item
1. must have a dsm-iv diagnosis of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
clinically stable schizophrenia, medication change
Item
2. must be clinically stable in the opinion of the patient s treating clinician with no change in antipsychotic medications or any dosage adjustment for 2 weeks or more preceding study enrollment as well as 2 weeks or more prior to the mri scan.
boolean
C0036341 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,3])
patient relatives
Item
relatives of patients:
boolean
C0080103 (UMLS CUI [1])
first degree relatives
Item
1. must be first degree relatives (full sibling, parent, or offspring)
boolean
C1517194 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
study subject
Item
all subjects:
boolean
C0681850 (UMLS CUI [1])
alcohol or cannabis dependence
Item
1. individuals who have alcohol and/or marijuana dependence
boolean
C0001973 (UMLS CUI [1])
C0006870 (UMLS CUI [2])
pregnancy
Item
2. individuals who are pregnant; urine pregnancy tests will be performed on all female volunteers of childbearing potential before each experimental session.
boolean
C0032961 (UMLS CUI [1])
mri contraindication
Item
3. individuals who are unable to undergo mri scanning due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia.
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
comorbidity
Item
4. individuals who have major medical illnesses that may affect normal brain functioning or safety lying in the scanner. examples of these conditions include, but not limited to, stroke, seizure, hiv/aids, uncontrolled high blood pressure, history of significant head trauma, cns infection or tumor based on medical history, peripheral vascular diseases, coagulopathies, history of superficial or deep vein thrombosis.
boolean
C0009488 (UMLS CUI [1])
substance use disorders
Item
5. individuals who partake in significant alcohol or other drug use, other than nicotine dependence. significant drug use is defined as a history of alcohol or other substance dependence in the past 6 months or current substance abuse, with the following few exceptions. subjects may be users of alcohol and/or marijuana but may not meet criteria for dependence.
boolean
C0038586 (UMLS CUI [1])
ophthalmological or neurological disorder
Item
6. individuals with significant ophthalmological and/or neurological conditions who have severe vision impairments such that they cannot follow a moving dot 60 cm in front of them are excluded. participants with reduced vision are included as long as they can follow a moving dot 60 cm in front of them.
boolean
C0015397 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
healthy controls
Item
healthy controls:
boolean
C2986479 (UMLS CUI [1])
psychiatric illness, dsm-iv
Item
1. individuals with psychiatric illness. the scid and structured interview for dsm-iv personality diagnoses (sidp) will be used to exclude volunteers with axis i and ii disorders.
boolean
C0004936 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
family history of psychotic illness
Item
2. individuals with a family history of psychotic illness according to family history research diagnostic criteria (fh-rdc).
boolean
C0241889 (UMLS CUI [1,1])
C1860474 (UMLS CUI [1,2])
C0871251 (UMLS CUI [1,3])
first degree relatives
Item
first degree relatives of patients:
boolean
C1517194 (UMLS CUI [1])
first degree relatives psychosis
Item
1. first degree relatives with a dsm-iv axis i diagnosis of psychosis, with the exception that a relative with a past history of psychosis will be included if symptoms are not present, and he/she is not taking antipsychotic drugs.
boolean
C1517194 (UMLS CUI [1])
axis ii disorder
Item
2. first degree relatives that meet sidp criteria for an axis ii disorder with exceptions made for relatives meeting criteria for schizophrenia spectrum personality disorders (sspd).
boolean
C0741358 (UMLS CUI [1])
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