ID

12814

Description

An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01662310

Link

https://clinicaltrials.gov/show/NCT01662310

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01662310

English

Eligibility Schizophrenia NCT01662310

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv)
Description

dsm-iv

Data type

boolean

Alias
UMLS CUI [1]
C0220952
have experienced an acute episode, with a positive and negative syndrome scale (panss) total score between 70 and 120 inclusive, at screening and baseline
Description

Acute Psychotic Episode; Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0237811
UMLS CUI [2]
C0451383
women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
Description

Infertility; hysterectomy; contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0021359
UMLS CUI [2]
C0020699
UMLS CUI [3]
C0700589
men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
Description

Contraceptive methods; Sperm donation

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0871414
be willing and capable to complete the questionnaires and able to take oral medications independently
Description

compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has drug dependence diagnosis according to dsm-iv (excluding nicotine and caffeine dependence) within 6 months before screening
Description

dsm-iv; drug dependence

Data type

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C1510472
participants with crohn's disease and hepatic or renal diseases
Description

Crohn Disease; renal diseases; hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
Description

neuroleptic malignant syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0027849
has had known or suspected stevens johnson syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
Description

stevens johnson syndrome; phenytoin

Data type

boolean

Alias
UMLS CUI [1]
C0038325
UMLS CUI [2]
C0031507
had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
Description

Treatment-resistant schizophrenia; clozapine

Data type

boolean

Alias
UMLS CUI [1]
C3544321
UMLS CUI [2]
C0009079
has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
Description

behavior suicide; behavior homicidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0004927
UMLS CUI [1,2]
C0038661
UMLS CUI [2,1]
C0004927
UMLS CUI [2,2]
C0745031
has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
Description

isocarboxazid; phenelzine

Data type

boolean

Alias
UMLS CUI [1]
C0022154
UMLS CUI [2]
C0031392
has received electroconvulsive therapy within 60 days before screening
Description

electroconvulsive therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
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Similar models

Eligibility Schizophrenia NCT01662310

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
dsm-iv
Item
have a diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv)
boolean
C0220952 (UMLS CUI [1])
Acute Psychotic Episode; Positive and negative syndrome scale
Item
have experienced an acute episode, with a positive and negative syndrome scale (panss) total score between 70 and 120 inclusive, at screening and baseline
boolean
C0237811 (UMLS CUI [1])
C0451383 (UMLS CUI [2])
Infertility; hysterectomy; contraceptive methods
Item
women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
boolean
C0021359 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Contraceptive methods; Sperm donation
Item
men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0700589 (UMLS CUI [1])
C0871414 (UMLS CUI [2])
compliance behavior
Item
be willing and capable to complete the questionnaires and able to take oral medications independently
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dsm-iv; drug dependence
Item
has drug dependence diagnosis according to dsm-iv (excluding nicotine and caffeine dependence) within 6 months before screening
boolean
C0220952 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
Crohn Disease; renal diseases; hepatic disease
Item
participants with crohn's disease and hepatic or renal diseases
boolean
C0010346 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
comorbidity
Item
has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
boolean
C0009488 (UMLS CUI [1])
neuroleptic malignant syndrome
Item
has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
boolean
C0027849 (UMLS CUI [1])
stevens johnson syndrome; phenytoin
Item
has had known or suspected stevens johnson syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
boolean
C0038325 (UMLS CUI [1])
C0031507 (UMLS CUI [2])
Treatment-resistant schizophrenia; clozapine
Item
had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
boolean
C3544321 (UMLS CUI [1])
C0009079 (UMLS CUI [2])
behavior suicide; behavior homicidal
Item
has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
boolean
C0004927 (UMLS CUI [1,1])
C0038661 (UMLS CUI [1,2])
C0004927 (UMLS CUI [2,1])
C0745031 (UMLS CUI [2,2])
isocarboxazid; phenelzine
Item
has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
boolean
C0022154 (UMLS CUI [1])
C0031392 (UMLS CUI [2])
electroconvulsive therapy
Item
has received electroconvulsive therapy within 60 days before screening
boolean
C0013806 (UMLS CUI [1])
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