ID

32307

Description

Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01724359

Link

https://clinicaltrials.gov/show/NCT01724359

Keywords

Versions (1)
  1. 10/26/18 10/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01724359

English

Eligibility Schizophrenia NCT01724359

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient meets the criteria for schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
patient is previously non-acute 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 efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
Description

Antipsychotic Agents Oral Dose Adequate | Prior Therapy Unsuccessful | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking | Change Antipsychotic Agent Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205411
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1272705
UMLS CUI [3]
C0235828
UMLS CUI [4]
C1744706
UMLS CUI [5,1]
C0036043
UMLS CUI [5,2]
C0332268
UMLS CUI [6,1]
C3489773
UMLS CUI [6,2]
C0332268
UMLS CUI [7,1]
C0392747
UMLS CUI [7,2]
C0040615
UMLS CUI [7,3]
C0205394
patient is healthy on the basis of a physical examination and vital signs at screening
Description

Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0518766
women 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
Description

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

Data type

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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
Description

Clozapine | Injection of depot antipsychotic agent | Risperidone Injection Active Long-term

Data type

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2]
C2585377
UMLS CUI [3,1]
C4084406
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0443252
patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Description

Medical condition Unstable Serious | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0438215
patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
Description

Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | Symptoms Neuroleptic Malignant Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0686347
UMLS CUI [3]
C0027849
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0027849
patients judged to be at high risk for adverse events, violence, or self-harm
Description

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

Data type

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
patients with known hypersensitivity to paliperidone er or to risperidone
Description

Hypersensitivity Paliperidone | Risperidone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0753678
UMLS CUI [2]
C0570837
patients with a current use or known history (over the past 6 months) of substance dependence
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Schizophrenia NCT01724359

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patient meets the criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents Oral Dose Adequate | Prior Therapy Unsuccessful | Lack of Efficacy | Intolerance to substance | Safety Lacking | Medication Compliance Lacking | Change Antipsychotic Agent Other
Item
patient is previously non-acute 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 efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
boolean
C0040615 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205411 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0235828 (UMLS CUI [3])
C1744706 (UMLS CUI [4])
C0036043 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C3489773 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C0392747 (UMLS CUI [7,1])
C0040615 (UMLS CUI [7,2])
C0205394 (UMLS CUI [7,3])
Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs
Item
patient 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])
C0518766 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods
Item
women 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])
Item Group
C0680251 (UMLS CUI)
Clozapine | Injection of depot antipsychotic agent | Risperidone Injection Active Long-term
Item
patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C2585377 (UMLS CUI [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
patients 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 | Symptoms Neuroleptic Malignant Syndrome
Item
patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
boolean
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
C0027849 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C0027849 (UMLS CUI [4,2])
High risk of Adverse event | High risk of Violence | High risk of Self-harm
Item
patients 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])
Hypersensitivity Paliperidone | Risperidone allergy
Item
patients with known hypersensitivity to paliperidone er or to risperidone
boolean
C0020517 (UMLS CUI [1,1])
C0753678 (UMLS CUI [1,2])
C0570837 (UMLS CUI [2])
Substance Dependence
Item
patients with a current use or known history (over the past 6 months) of substance dependence
boolean
C0038580 (UMLS CUI [1])
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