ID

32170

Description

28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years; ODM derived from: https://clinicaltrials.gov/show/NCT00946985

Link

https://clinicaltrials.gov/show/NCT00946985

Keywords

Versions (1)
  1. 10/22/18 10/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00946985

English

Eligibility Schizophrenia NCT00946985

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the institutional review board (irb) or independent ethics committee (iec), as appropriate
Description

Comprehension Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0021430
all patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must have a current diagnosis of schizophrenia
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
Description

Breakthrough Symptoms Period Quantity | Requirement Change Patient care | Dose Increase | Investigational New Drugs Additional | Hospitalization | Psychiatric patient care Increase

Data type

boolean

Alias
UMLS CUI [1,1]
C0444503
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0017313
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0442805
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C1524062
UMLS CUI [5]
C0019993
UMLS CUI [6,1]
C0597312
UMLS CUI [6,2]
C0442805
women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
Description

Postmenopausal state | Female Sterilization | Gender Infertility | 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]
C0021359
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0036899
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0700589
women of childbearing potential must have a negative urine pregnancy test at screening
Description

Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
Description

Informed Consent Unable | Psychiatric hospitalization Involuntary

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0748061
UMLS CUI [2,2]
C2986385
have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
Description

Suicide attempt | At risk for suicide | At risk Physical aggression

Data type

boolean

Alias
UMLS CUI [1]
C0038663
UMLS CUI [2]
C0563664
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0424323
have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
Description

Urine drug screen positive Barbiturates | DRUG SCREEN URINE COCAINE POSITIVE | Urine drug screen positive Amphetamines | DRUG SCREEN URINE OPIATE POSITIVE

Data type

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0004745
UMLS CUI [2]
C0743298
UMLS CUI [3,1]
C0743300
UMLS CUI [3,2]
C0002667
UMLS CUI [4]
C0743299
patients who are in their first episode of psychosis
Description

Psychotic episode First

Data type

boolean

Alias
UMLS CUI [1,1]
C0338614
UMLS CUI [1,2]
C0205435
patients currently meeting criteria for any other axis i diagnosis except substance abuse or an axis ii diagnosis of mental retardation or borderline personality disorder
Description

Axis I diagnosis Other | Exception Substance Use Disorders | Axis II diagnosis | Mental Retardation | Borderline Personality Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038586
UMLS CUI [3]
C0270288
UMLS CUI [4]
C0025362
UMLS CUI [5]
C0006012
meet the diagnostic and statistical manual of mental health disorders fourth edition (dsm-iv) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry
Description

Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, risperdal®, risperdal® consta®, or invega® or its excipients
Description

Hypersensitivity Paliperidone palmitate | Risperidone allergy | Hypersensitivity Risperdal | Hypersensitivity Risperdal Consta | Hypersensitivity Invega | Intolerance to Paliperidone palmitate | Intolerance to Risperidone | Intolerance to Risperdal | Intolerance to Risperdal Consta | Intolerance to Invega | Hypersensitivity Paliperidone palmitate Excipient | Hypersensitivity Risperidone Excipient | Hypersensitivity Risperdal Excipient | Hypersensitivity Risperdal Consta Excipient | Hypersensitivity Invega Excipient | Intolerance to Paliperidone palmitate Excipient | Intolerance to Risperidone Excipient | Intolerance to Risperdal Excipient | Intolerance to Risperdal Consta Excipient | Intolerance to Invega Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2719626
UMLS CUI [2]
C0570837
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0592071
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1320098
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C1828935
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C2719626
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0073393
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0592071
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C1320098
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C1828935
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C2719626
UMLS CUI [11,3]
C0015237
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0073393
UMLS CUI [12,3]
C0015237
UMLS CUI [13,1]
C0020517
UMLS CUI [13,2]
C0592071
UMLS CUI [13,3]
C0015237
UMLS CUI [14,1]
C0020517
UMLS CUI [14,2]
C1320098
UMLS CUI [14,3]
C0015237
UMLS CUI [15,1]
C0020517
UMLS CUI [15,2]
C1828935
UMLS CUI [15,3]
C0015237
UMLS CUI [16,1]
C1744706
UMLS CUI [16,2]
C2719626
UMLS CUI [16,3]
C0015237
UMLS CUI [17,1]
C1744706
UMLS CUI [17,2]
C0073393
UMLS CUI [17,3]
C0015237
UMLS CUI [18,1]
C1744706
UMLS CUI [18,2]
C0592071
UMLS CUI [18,3]
C0015237
UMLS CUI [19,1]
C1744706
UMLS CUI [19,2]
C1320098
UMLS CUI [19,3]
C0015237
UMLS CUI [20,1]
C1744706
UMLS CUI [20,2]
C1828935
UMLS CUI [20,3]
C0015237
patients who received long acting therapy (lat) treatment within 2 injection cycles prior to screening
Description

Therapy Active Long-term | Injection Course Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0443252
UMLS CUI [2,1]
C1533685
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
women who are pregnant or breast-feeding, or planning to become pregnant.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
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Similar models

Eligibility Schizophrenia NCT00946985

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Comprehension Informed Consent
Item
patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the institutional review board (irb) or independent ethics committee (iec), as appropriate
boolean
C0162340 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Informed Consent
Item
all patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
Schizophrenia
Item
must have a current diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Breakthrough Symptoms Period Quantity | Requirement Change Patient care | Dose Increase | Investigational New Drugs Additional | Hospitalization | Psychiatric patient care Increase
Item
must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
boolean
C0444503 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0017313 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C1524062 (UMLS CUI [4,2])
C0019993 (UMLS CUI [5])
C0597312 (UMLS CUI [6,1])
C0442805 (UMLS CUI [6,2])
Postmenopausal state | Female Sterilization | Gender Infertility | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods
Item
women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0021359 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0036899 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
Childbearing Potential Urine pregnancy test negative
Item
women of childbearing potential must have a negative urine pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Protocol Compliance
Item
patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Psychiatric hospitalization Involuntary
Item
patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0748061 (UMLS CUI [2,1])
C2986385 (UMLS CUI [2,2])
Suicide attempt | At risk for suicide | At risk Physical aggression
Item
have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
boolean
C0038663 (UMLS CUI [1])
C0563664 (UMLS CUI [2])
C1444641 (UMLS CUI [3,1])
C0424323 (UMLS CUI [3,2])
Urine drug screen positive Barbiturates | DRUG SCREEN URINE COCAINE POSITIVE | Urine drug screen positive Amphetamines | DRUG SCREEN URINE OPIATE POSITIVE
Item
have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
boolean
C0743300 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
C0743298 (UMLS CUI [2])
C0743300 (UMLS CUI [3,1])
C0002667 (UMLS CUI [3,2])
C0743299 (UMLS CUI [4])
Psychotic episode First
Item
patients who are in their first episode of psychosis
boolean
C0338614 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Axis I diagnosis Other | Exception Substance Use Disorders | Axis II diagnosis | Mental Retardation | Borderline Personality Disorder
Item
patients currently meeting criteria for any other axis i diagnosis except substance abuse or an axis ii diagnosis of mental retardation or borderline personality disorder
boolean
C0270287 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038586 (UMLS CUI [2,2])
C0270288 (UMLS CUI [3])
C0025362 (UMLS CUI [4])
C0006012 (UMLS CUI [5])
Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
meet the diagnostic and statistical manual of mental health disorders fourth edition (dsm-iv) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
Hypersensitivity Paliperidone palmitate | Risperidone allergy | Hypersensitivity Risperdal | Hypersensitivity Risperdal Consta | Hypersensitivity Invega | Intolerance to Paliperidone palmitate | Intolerance to Risperidone | Intolerance to Risperdal | Intolerance to Risperdal Consta | Intolerance to Invega | Hypersensitivity Paliperidone palmitate Excipient | Hypersensitivity Risperidone Excipient | Hypersensitivity Risperdal Excipient | Hypersensitivity Risperdal Consta Excipient | Hypersensitivity Invega Excipient | Intolerance to Paliperidone palmitate Excipient | Intolerance to Risperidone Excipient | Intolerance to Risperdal Excipient | Intolerance to Risperdal Consta Excipient | Intolerance to Invega Excipient
Item
patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, risperdal®, risperdal® consta®, or invega® or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C2719626 (UMLS CUI [1,2])
C0570837 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0592071 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1320098 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C1828935 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C2719626 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0073393 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0592071 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C1320098 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C1828935 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C2719626 (UMLS CUI [11,2])
C0015237 (UMLS CUI [11,3])
C0020517 (UMLS CUI [12,1])
C0073393 (UMLS CUI [12,2])
C0015237 (UMLS CUI [12,3])
C0020517 (UMLS CUI [13,1])
C0592071 (UMLS CUI [13,2])
C0015237 (UMLS CUI [13,3])
C0020517 (UMLS CUI [14,1])
C1320098 (UMLS CUI [14,2])
C0015237 (UMLS CUI [14,3])
C0020517 (UMLS CUI [15,1])
C1828935 (UMLS CUI [15,2])
C0015237 (UMLS CUI [15,3])
C1744706 (UMLS CUI [16,1])
C2719626 (UMLS CUI [16,2])
C0015237 (UMLS CUI [16,3])
C1744706 (UMLS CUI [17,1])
C0073393 (UMLS CUI [17,2])
C0015237 (UMLS CUI [17,3])
C1744706 (UMLS CUI [18,1])
C0592071 (UMLS CUI [18,2])
C0015237 (UMLS CUI [18,3])
C1744706 (UMLS CUI [19,1])
C1320098 (UMLS CUI [19,2])
C0015237 (UMLS CUI [19,3])
C1744706 (UMLS CUI [20,1])
C1828935 (UMLS CUI [20,2])
C0015237 (UMLS CUI [20,3])
Therapy Active Long-term | Injection Course Quantity
Item
patients who received long acting therapy (lat) treatment within 2 injection cycles prior to screening
boolean
C0087111 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C1533685 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast-feeding, or planning to become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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