ID

32261

Description

A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01541371

Link

https://clinicaltrials.gov/show/NCT01541371

Keywords

Versions (1)
  1. 10/25/18 10/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01541371

English

Eligibility Schizophrenia NCT01541371

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants meeting diagnostic and statistical manual of mental disorders-iv (dsm-iv) diagnosis criteria of schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
participant receiving full course of treatment (6-8 weeks) at correct dose (dose range recommended by the instruction) of risperdal, zyprexa or seroquel before enrollment, was poorly controlled and had to change medication because of unsatisfying efficacy, tolerability or safety issues, or other reason
Description

Risperdal Dose Correct | Zyprexa Dose Correct | Seroquel Dose Correct | Study Subject Poorly controlled | Change of medication Required | Etiology Effectiveness Unsatisfactory | Etiology Intolerance to substance | Etiology Safety Problem

Data type

boolean

Alias
UMLS CUI [1,1]
C0592071
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2349182
UMLS CUI [2,1]
C0527258
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C2349182
UMLS CUI [3,1]
C0287163
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C2349182
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0580105
UMLS CUI [5,2]
C1514873
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C1280519
UMLS CUI [6,3]
C0439856
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C1744706
UMLS CUI [8,1]
C0015127
UMLS CUI [8,2]
C0036043
UMLS CUI [8,3]
C0033213
participant in the non-acute phase during screening received treatment with any of above three antipsychotics within 4 weeks before enrollment and state of illness was relatively stable
Description

Antipsychotic Agents Quantity | Stable Disease Relative

Data type

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0677946
UMLS CUI [2,2]
C0205345
7. 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. effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. female participants must also have a negative urine pregnancy test at screening
Description

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Hormonal contraception | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch | Partner had vasectomy | Gender Urine pregnancy test negative

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
UMLS CUI [5]
C2985296
UMLS CUI [6]
C1656586
UMLS CUI [7]
C0021900
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C2985284
UMLS CUI [10]
C0420842
UMLS CUI [11,1]
C0079399
UMLS CUI [11,2]
C0430057
participant willing to and who could complete questionnaire by himself
Description

Questionnaires Completion Self

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0036588
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant receiving treatment with clozapine or risperidone microspheres for injection (hengde) within 3 months before screening
Description

Clozapine Injection | Risperidone microspheres Injection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C1828121
UMLS CUI [2,1]
C1337134
UMLS CUI [2,2]
C1828121
participant having history of seizure except febrile convulsion (seizures that occur during a febrile episode [fever])
Description

Seizure | Exception Febrile Convulsion

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009952
participant having refractory schizophrenia (previous treatment with unsatisfied efficacy of 2 or more than 2 kinds of antipsychotics with different chemical structure after adequate dose and duration)
Description

Refractory schizophrenia | Antipsychotic Agents Different Quantity | Treatment Effectiveness Unsatisfactory

Data type

boolean

Alias
UMLS CUI [1]
C2063865
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1280519
UMLS CUI [3,3]
C0439856
participant receiving electric shock treatment within 1 month before screening
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
participant having serious, unstable physical diseases
Description

Physical illness Serious Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
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Similar models

Eligibility Schizophrenia NCT01541371

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
participants meeting diagnostic and statistical manual of mental disorders-iv (dsm-iv) diagnosis criteria of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Risperdal Dose Correct | Zyprexa Dose Correct | Seroquel Dose Correct | Study Subject Poorly controlled | Change of medication Required | Etiology Effectiveness Unsatisfactory | Etiology Intolerance to substance | Etiology Safety Problem
Item
participant receiving full course of treatment (6-8 weeks) at correct dose (dose range recommended by the instruction) of risperdal, zyprexa or seroquel before enrollment, was poorly controlled and had to change medication because of unsatisfying efficacy, tolerability or safety issues, or other reason
boolean
C0592071 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C0527258 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C2349182 (UMLS CUI [2,3])
C0287163 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C2349182 (UMLS CUI [3,3])
C0681850 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0580105 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C1280519 (UMLS CUI [6,2])
C0439856 (UMLS CUI [6,3])
C0015127 (UMLS CUI [7,1])
C1744706 (UMLS CUI [7,2])
C0015127 (UMLS CUI [8,1])
C0036043 (UMLS CUI [8,2])
C0033213 (UMLS CUI [8,3])
Antipsychotic Agents Quantity | Stable Disease Relative
Item
participant in the non-acute phase during screening received treatment with any of above three antipsychotics within 4 weeks before enrollment and state of illness was relatively stable
boolean
C0040615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0677946 (UMLS CUI [2,1])
C0205345 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Hormonal contraception | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive patch | Partner had vasectomy | Gender Urine pregnancy test negative
Item
7. 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. effective methods of birth control include prescription hormonal contraceptives, contraceptive injections, intrauterine devices, double barrier method, contraceptive patch and male partner sterilization. female participants must also have a negative urine pregnancy test at screening
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])
C2985296 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C2985284 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C0079399 (UMLS CUI [11,1])
C0430057 (UMLS CUI [11,2])
Questionnaires Completion Self
Item
participant willing to and who could complete questionnaire by himself
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clozapine Injection | Risperidone microspheres Injection
Item
participant receiving treatment with clozapine or risperidone microspheres for injection (hengde) within 3 months before screening
boolean
C0009079 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C1337134 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Seizure | Exception Febrile Convulsion
Item
participant having history of seizure except febrile convulsion (seizures that occur during a febrile episode [fever])
boolean
C0036572 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009952 (UMLS CUI [2,2])
Refractory schizophrenia | Antipsychotic Agents Different Quantity | Treatment Effectiveness Unsatisfactory
Item
participant having refractory schizophrenia (previous treatment with unsatisfied efficacy of 2 or more than 2 kinds of antipsychotics with different chemical structure after adequate dose and duration)
boolean
C2063865 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1280519 (UMLS CUI [3,2])
C0439856 (UMLS CUI [3,3])
Electroconvulsive Therapy
Item
participant receiving electric shock treatment within 1 month before screening
boolean
C0013806 (UMLS CUI [1])
Physical illness Serious Unstable
Item
participant having serious, unstable physical diseases
boolean
C0683323 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
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