ID

32264

Beschreibung

A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01577160

Link

https://clinicaltrials.gov/show/NCT01577160

Stichworte

Versionen (1)
  1. 25.10.18 25.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01577160

Englisch

Eligibility Schizophrenia NCT01577160

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who are diagnosed with schizophrenia (according to diagnostic and statistical manual of mental disorders [edition 4] criteria)
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
participants with clinical global impression-severity (cgi-s) score greater than or equal to 4 points (moderately ill) at screening
Beschreibung

Clinical global impression scale

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0029151
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
Beschreibung

Questionnaire Completion Self

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0036588
participants who are compliant with self-medication or can receive consistent help or support
Beschreibung

Compliance behavior Self Medication | Ability Receive Support

Datentyp

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
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Beschreibung

Neuroleptic Malignant Syndrome | High fever | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Hypertensive disease | Myalgia | Weakness

Datentyp

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0743973
UMLS CUI [3]
C0026837
UMLS CUI [4]
C0040822
UMLS CUI [5]
C0009676
UMLS CUI [6]
C0700590
UMLS CUI [7]
C0039231
UMLS CUI [8]
C0020538
UMLS CUI [9]
C0231528
UMLS CUI [10]
C3714552
participants with allergy or hypersensitivity to risperidone or paliperidone
Beschreibung

Risperidone allergy | Hypersensitivity Paliperidone

Datentyp

boolean

Alias
UMLS CUI [1]
C0570837
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0753678
participants who have taken clozapine, or have been exposed to the study drug within one month before screening
Beschreibung

Clozapine | Exposure to Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0013230
participants who have been treated with the long acting antipsychotic injection within 28 days
Beschreibung

Injection of depot antipsychotic agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2585377
participants with significant risk including suicide or aggressive behavior
Beschreibung

Study Subject At risk | At risk for suicide | At risk Aggressive behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1444641
UMLS CUI [2]
C0563664
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0001807
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Ähnliche Modelle

Eligibility Schizophrenia NCT01577160

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participants who are diagnosed with schizophrenia (according to diagnostic and statistical manual of mental disorders [edition 4] criteria)
boolean
C0036341 (UMLS CUI [1])
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 | Oral contraception | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch
Item
childbearing potential women who consented 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])
C0029151 (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 Self
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])
C0036588 (UMLS CUI [1,3])
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])
Item Group
C0680251 (UMLS CUI)
Neuroleptic Malignant Syndrome | High fever | Muscle Rigidity | Tremor | Confusion | Increased sweating | Tachycardia | Hypertensive disease | Myalgia | Weakness
Item
participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
boolean
C0027849 (UMLS CUI [1])
C0743973 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
C0040822 (UMLS CUI [4])
C0009676 (UMLS CUI [5])
C0700590 (UMLS CUI [6])
C0039231 (UMLS CUI [7])
C0020538 (UMLS CUI [8])
C0231528 (UMLS CUI [9])
C3714552 (UMLS CUI [10])
Risperidone allergy | Hypersensitivity Paliperidone
Item
participants with allergy or hypersensitivity to risperidone or paliperidone
boolean
C0570837 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
Clozapine | Exposure to Investigational New Drugs
Item
participants who have taken clozapine, or have been exposed to the study drug within one month before screening
boolean
C0009079 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Injection of depot antipsychotic agent
Item
participants who have been treated with the long acting antipsychotic injection within 28 days
boolean
C2585377 (UMLS CUI [1])
Study Subject At risk | At risk for suicide | At risk Aggressive behavior
Item
participants with significant risk including suicide or aggressive behavior
boolean
C0681850 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0001807 (UMLS CUI [3,2])
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