ID

32011

Beskrivning

An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00460512

Länk

https://clinicaltrials.gov/show/NCT00460512

Nyckelord

Versioner (1)
  1. 2018-10-11 2018-10-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00460512

Engelsk

Eligibility Schizophrenia NCT00460512

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant meets the diagnostic and statistical manual of mental disorders (edition 4) criteria for schizophrenia
Beskrivning

Criteria Fulfill Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0036341
participant is previously non-acute (on the same antipsychotic medication used for the treatment of schizophrenia and clinical global impression-severity [cgi-s] change less than or equal to 1 in the past 4 weeks before enrollment) and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Beskrivning

Antipsychotic Agents Schizophrenia | CGI - Severity of Illness | Oral antipsychotic therapy | Prior Therapy Unsuccessful | Lack of Efficacy | Intolerance to substance | Lack Safety | Compliance behavior Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0036341
UMLS CUI [2]
C3639887
UMLS CUI [3]
C4273790
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1272705
UMLS CUI [5]
C0235828
UMLS CUI [6]
C1744706
UMLS CUI [7,1]
C0332268
UMLS CUI [7,2]
C0036043
UMLS CUI [8,1]
C1321605
UMLS CUI [8,2]
C0332268
participant is healthy on the basis of a physical examination and vital signs at screening
Beskrivning

Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0150404
female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
Beskrivning

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0241028
UMLS CUI [4,3]
C0700589
participants must be willing and able to fill out self-administered questionnaires
Beskrivning

Questionnaires Self-Administered Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C1519231
UMLS CUI [1,3]
C0205197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants on clozapine, any conventional depot neuroleptic or risperidone long-acting injection during the last 3 months
Beskrivning

Clozapine | Depot neuroleptic | Risperidone Injection Active Long-term

Datatyp

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0086129
UMLS CUI [3,1]
C4084406
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Beskrivning

Medical condition Unstable Serious | Laboratory test result abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0438215
participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Beskrivning

Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | High fever | Rigid muscle | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Muscle Weakness

Datatyp

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0686347
UMLS CUI [3]
C0027849
UMLS CUI [4]
C0743973
UMLS CUI [5]
C0555752
UMLS CUI [6]
C0040822
UMLS CUI [7]
C0009676
UMLS CUI [8]
C0700590
UMLS CUI [9]
C0039231
UMLS CUI [10]
C0497247
UMLS CUI [11]
C0231528
UMLS CUI [12]
C0151786
participants judged to be at high risk for adverse events, violence or self-harm
Beskrivning

High risk of Adverse events | High risk of Violence | High risk of Self-harm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0042693
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0424366
participants with a current use or known history (over the past 6 months) of substance dependence according to diagnostic and statistical manual of mental disorders (edition 4) criteria
Beskrivning

Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Schizophrenia NCT00460512

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill Schizophrenia
Item
participant meets the diagnostic and statistical manual of mental disorders (edition 4) criteria for schizophrenia
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Antipsychotic Agents Schizophrenia | CGI - Severity of Illness | Oral antipsychotic therapy | Prior Therapy Unsuccessful | Lack of Efficacy | Intolerance to substance | Lack Safety | Compliance behavior Lacking
Item
participant is previously non-acute (on the same antipsychotic medication used for the treatment of schizophrenia and clinical global impression-severity [cgi-s] change less than or equal to 1 in the past 4 weeks before enrollment) and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
boolean
C0040615 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C3639887 (UMLS CUI [2])
C4273790 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0235828 (UMLS CUI [5])
C1744706 (UMLS CUI [6])
C0332268 (UMLS CUI [7,1])
C0036043 (UMLS CUI [7,2])
C1321605 (UMLS CUI [8,1])
C0332268 (UMLS CUI [8,2])
Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs
Item
participant is healthy on the basis of a physical examination and vital signs at screening
boolean
C1708335 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0150404 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods
Item
female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Questionnaires Self-Administered Completion
Item
participants must be willing and able to fill out self-administered questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clozapine | Depot neuroleptic | Risperidone Injection Active Long-term
Item
participants on clozapine, any conventional depot neuroleptic or risperidone long-acting injection during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0086129 (UMLS CUI [2,2])
C4084406 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Medical condition Unstable Serious | Laboratory test result abnormal
Item
participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2])
Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | High fever | Rigid muscle | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Muscle Weakness
Item
participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and 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
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
C0027849 (UMLS CUI [3])
C0743973 (UMLS CUI [4])
C0555752 (UMLS CUI [5])
C0040822 (UMLS CUI [6])
C0009676 (UMLS CUI [7])
C0700590 (UMLS CUI [8])
C0039231 (UMLS CUI [9])
C0497247 (UMLS CUI [10])
C0231528 (UMLS CUI [11])
C0151786 (UMLS CUI [12])
High risk of Adverse events | High risk of Violence | High risk of Self-harm
Item
participants judged to be at high risk for adverse events, violence or self-harm
boolean
C0332167 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0042693 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0424366 (UMLS CUI [3,2])
Substance Dependence
Item
participants with a current use or known history (over the past 6 months) of substance dependence according to diagnostic and statistical manual of mental disorders (edition 4) criteria
boolean
C0038580 (UMLS CUI [1])
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