ID

32306

Description

Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01662648

Link

https://clinicaltrials.gov/show/NCT01662648

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 NCT01662648

English

Eligibility Schizophrenia NCT01662648

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant diagnosed with schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
participant's previous treatment of schizophrenia is considered unsuccessful
Description

Prior Therapy Unsuccessful Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0036341
participant is healthy on the basis of a physical examination and vital signs
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, 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
be willing and able to fill out self-administered questionnaires
Description

Completion Questionnaires Self-Administered

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used clozapine or risperdal consta during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
Description

Clozapine | Risperdal Consta | Antipsychotic Agents conventional

Data type

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2]
C1320098
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0439858
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
inability to swallow the study medication whole with the aid of water
Description

Lacking Able to swallow Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0013230
pregnant or breast-feeding female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
Description

Tardive Dyskinesia | Symptoms Tardive Dyskinesia

Data type

boolean

Alias
UMLS CUI [1]
C0686347
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0686347
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Similar models

Eligibility Schizophrenia NCT01662648

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participant diagnosed with schizophrenia
boolean
C0036341 (UMLS CUI [1])
Prior Therapy Unsuccessful Schizophrenia
Item
participant's previous treatment of schizophrenia is considered unsuccessful
boolean
C1514463 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs
Item
participant is healthy on the basis of a physical examination and vital signs
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, 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])
Completion Questionnaires Self-Administered
Item
be willing and able to fill out self-administered questionnaires
boolean
C0205197 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1519231 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clozapine | Risperdal Consta | Antipsychotic Agents conventional
Item
have used clozapine or risperdal consta during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C1320098 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C0439858 (UMLS CUI [3,2])
High risk of Adverse event | High risk of Violence | High risk of Self-harm
Item
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])
Lacking Able to swallow Investigational New Drugs
Item
inability to swallow the study medication whole with the aid of water
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tardive Dyskinesia | Symptoms Tardive Dyskinesia
Item
history or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
boolean
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
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