ID

23798

Description

ACP-104 in Acutely Psychotic Subjects With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00490516

Link

https://clinicaltrials.gov/show/NCT00490516

Keywords

Versions (1)
  1. 7/13/17 7/13/17 -
Uploaded on

July 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00490516

English

Eligibility Schizophrenia NCT00490516

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female; 18-60 years of age
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the subject is physically healthy and medically stable.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C3898900
the subject is able to provide informed consent
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the subject has been diagnosed with schizophrenia for at least 1 year
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0036341
currently experiencing an acute episode of psychosis
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0338614
the subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1321605
the subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0085537
if the subject is female, subject must be of non-childbearing potential - or- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if the subject is a pregnant or lactating (breast-feeding) female.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
the subject has a significant risk of suicide, homicide, and/or harm to self or others.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0424366
UMLS CUI [1,3]
C0549013
subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C3844714
the subject is experiencing his/her first episode of schizophrenia.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0439615
the subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation).
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1,1]
C0033975
UMLS CUI [1,2]
C0004352
UMLS CUI [1,3]
C0524528
the subject has been prescribed or exposed to clozapine before.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C0009079
the subject has donated blood or plasma within 56 days prior to the screening visit.
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0005795
UMLS CUI [1,2]
C0860067
the subject has participated in any clinical study within 30 days prior to the screening visit.
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1]
C0008972
in addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0220825
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Similar models

Eligibility Schizophrenia NCT00490516

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female; 18-60 years of age
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
the subject is physically healthy and medically stable.
boolean
C3898900 (UMLS CUI [1])
ID.3
Item
the subject is able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
ID.4
Item
the subject has been diagnosed with schizophrenia for at least 1 year
boolean
C0036341 (UMLS CUI [1])
ID.5
Item
currently experiencing an acute episode of psychosis
boolean
C0338614 (UMLS CUI [1])
ID.6
Item
the subject is willing to comply with all study-related events including in-patient hospitalization for at least 3 weeks.
boolean
C0019993 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
ID.7
Item
the subject has a caregiver who is willing and able to support the subject to ensure compliance with treatment and outpatient visits.
boolean
C0085537 (UMLS CUI [1])
ID.8
Item
if the subject is female, subject must be of non-childbearing potential - or- if she is capable of becoming pregnant, agrees to commit to use one of the approved methods of contraception, as defined by the protocol.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.9
Item
if the subject is a pregnant or lactating (breast-feeding) female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.10
Item
the subject has a significant risk of suicide, homicide, and/or harm to self or others.
boolean
C0563664 (UMLS CUI [1,1])
C0424366 (UMLS CUI [1,2])
C0549013 (UMLS CUI [1,3])
ID.11
Item
subject's psychotic symptoms have not improved with a therapeutic dose of antipsychotic treatment over the last 2 years.
boolean
C0871189 (UMLS CUI [1,1])
C3844714 (UMLS CUI [1,2])
ID.12
Item
the subject is experiencing his/her first episode of schizophrenia.
boolean
C0036341 (UMLS CUI [1,1])
C0439615 (UMLS CUI [1,2])
ID.13
Item
the subject has another psychotic disorder or has a history of autistic disorder or other pervasive developmental disorder (for example, mental retardation).
boolean
C0033975 (UMLS CUI [1,1])
C0004352 (UMLS CUI [1,2])
C0524528 (UMLS CUI [1,3])
ID.14
Item
the subject has been prescribed or exposed to clozapine before.
boolean
C0009079 (UMLS CUI [1])
ID.15
Item
the subject has donated blood or plasma within 56 days prior to the screening visit.
boolean
C0005795 (UMLS CUI [1,1])
C0860067 (UMLS CUI [1,2])
ID.16
Item
the subject has participated in any clinical study within 30 days prior to the screening visit.
boolean
C0008972 (UMLS CUI [1])
ID.17
Item
in addition to the criteria described above, subjects will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of the subject's health, including psychosis (mental health -the extent to which subject is unable to think clearly), heart condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline condition does not meet all protocol-specified entry criteria).
boolean
C0220825 (UMLS CUI [1])
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