ID

32109

Descripción

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

Palabras clave

Versiones (1)
  1. 18/10/18 18/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00761189

Inglés

Eligibility Schizophrenia NCT00761189

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

Clinical global impression scale

Tipo de datos

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)
Descripción

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

Tipo de datos

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
Descripción

Questionnaire Completion

Tipo de datos

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
Descripción

Compliance behavior Self Medication | Ability Receive Support

Tipo de datos

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)
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
Exclusion Criteria
Descripción

Exclusion Criteria

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

Neuroleptic Malignant Syndrome

Tipo de datos

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)
Descripción

Resistant to Therapeutic procedure | Antipsychotic Agents Quantity failed

Tipo de datos

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.)
Descripción

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

Tipo de datos

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
Descripción

Exposure to Investigational New Drugs

Tipo de datos

boolean

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

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

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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