ID

32109

Beschrijving

PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00761189

Link

https://clinicaltrials.gov/show/NCT00761189

Trefwoorden

Versies (1)
  1. 18-10-18 18-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00761189

Engels

Eligibility Schizophrenia NCT00761189

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with clinical global impression-severity (cgi-s) score greater than or equal to 4 points (moderately ill) at screening
Beschrijving

Clinical global impression scale

Datatype

boolean

Alias
UMLS CUI [1]
C3639708
childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Beschrijving

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1656586
UMLS CUI [4]
C0021900
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6]
C2985284
participants who are capable of and willing to fill out the questionnaire for themselves
Beschrijving

Questionnaire Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
participants who are compliant with self-medication or can receive consistent help or support
Beschrijving

Compliance behavior Self Medication | Ability Receive Support

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0036600
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1521721
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
Beschrijving

Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with the past history of neuroleptic malignant syndrome (nms)
Beschrijving

Neuroleptic Malignant Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0027849
participants with treatment resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
Beschrijving

Resistant to Therapeutic procedure | Antipsychotic Agents Quantity failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
Beschrijving

Gastrointestinal stenosis Severe | Gastrointestinal stenosis Severe Iatrogenic | Lacking Able to swallow Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0521587
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0521587
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0439669
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C0013230
participants who have been exposed to the study drug within one month before screening
Beschrijving

Exposure to Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
participants with significant risk including suicide or aggressive behavior
Beschrijving

Risk Significant | At risk for suicide | At risk Aggressive behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0563664
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0001807
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Similar models

Eligibility Schizophrenia NCT00761189

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Clinical global impression scale
Item
participants with clinical global impression-severity (cgi-s) score greater than or equal to 4 points (moderately ill) at screening
boolean
C3639708 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch
Item
childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C2985284 (UMLS CUI [6])
Questionnaire Completion
Item
participants who are capable of and willing to fill out the questionnaire for themselves
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Compliance behavior Self Medication | Ability Receive Support
Item
participants who are compliant with self-medication or can receive consistent help or support
boolean
C1321605 (UMLS CUI [1,1])
C0036600 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1521721 (UMLS CUI [2,3])
Schizophrenia
Item
have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv)
boolean
C0036341 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neuroleptic Malignant Syndrome
Item
participants with the past history of neuroleptic malignant syndrome (nms)
boolean
C0027849 (UMLS CUI [1])
Resistant to Therapeutic procedure | Antipsychotic Agents Quantity failed
Item
participants with treatment resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
boolean
C0332325 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Gastrointestinal stenosis Severe | Gastrointestinal stenosis Severe Iatrogenic | Lacking Able to swallow Investigational New Drugs
Item
participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (the study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
boolean
C0521587 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521587 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0439669 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
Exposure to Investigational New Drugs
Item
participants who have been exposed to the study drug within one month before screening
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Risk Significant | At risk for suicide | At risk Aggressive behavior
Item
participants with significant risk including suicide or aggressive behavior
boolean
C0035647 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0001807 (UMLS CUI [3,2])
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