ID

32039

Beschreibung

A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00604279

Link

https://clinicaltrials.gov/show/NCT00604279

Stichworte

Versionen (1)
  1. 15.10.18 15.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00604279

Englisch

Eligibility Schizophrenia NCT00604279

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who meet diagnostic criteria for schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
Beschreibung

Schizophrenia Disease length | Schizophrenia, Disorganized | Schizophrenia, Catatonic | Paranoid Schizophrenia | Residual schizophrenia | Undifferentiated schizophrenia | Medical Records Consistent with Schizophrenia | Documentation Consistent with Schizophrenia | Verbal information Consistent with Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0036347
UMLS CUI [3]
C0036344
UMLS CUI [4]
C0036349
UMLS CUI [5]
C0036351
UMLS CUI [6]
C0392322
UMLS CUI [7,1]
C0025102
UMLS CUI [7,2]
C0332290
UMLS CUI [7,3]
C0036341
UMLS CUI [8,1]
C0175636
UMLS CUI [8,2]
C0332290
UMLS CUI [8,3]
C0036341
UMLS CUI [9,1]
C1549471
UMLS CUI [9,2]
C0332290
UMLS CUI [9,3]
C0036341
a total positive and negative syndrome scale (panss) score between 60 and 120, inclusive, at screening and baseline
Beschreibung

PANSS score

Datentyp

boolean

Alias
UMLS CUI [1]
C0451383
body mass index (bmi) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
Beschreibung

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

Datentyp

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 capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study exclusion criteria:
Beschreibung

Investigational New Drugs Self Administration | Supplementation therapy Oral | Investigational New Drugs Administration Assistance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0036589
UMLS CUI [2,1]
C1735596
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C1269765
a primary, active dsm-iv diagnosis on axis i other than schizophrenia
Beschreibung

Exclusion Criteria | Axis I diagnosis Primary | Exception Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0036341
a decrease of at least 25 percent in the total panss score between screening and baseline
Beschreibung

Exclusion Criteria | PANSS score Decrease Percentage

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0451383
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C0439165
participants who have previously participated in this study
Beschreibung

Exclusion Criteria | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C2348568
a dsm-iv diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
Beschreibung

Exclusion Criteria | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
history of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
Beschreibung

Exclusion Criteria | Treatment-resistant schizophrenia | Antipsychotic Agents Different Quantity | Antipsychotic Agents Maximum Tolerated Dose | Response failed

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C3544321
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C1705242
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0040615
UMLS CUI [4,2]
C0752079
UMLS CUI [5,1]
C1704632
UMLS CUI [5,2]
C0231175
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Ähnliche Modelle

Eligibility Schizophrenia NCT00604279

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Disease length | Schizophrenia, Disorganized | Schizophrenia, Catatonic | Paranoid Schizophrenia | Residual schizophrenia | Undifferentiated schizophrenia | Medical Records Consistent with Schizophrenia | Documentation Consistent with Schizophrenia | Verbal information Consistent with Schizophrenia
Item
participants who meet diagnostic criteria for schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0036347 (UMLS CUI [2])
C0036344 (UMLS CUI [3])
C0036349 (UMLS CUI [4])
C0036351 (UMLS CUI [5])
C0392322 (UMLS CUI [6])
C0025102 (UMLS CUI [7,1])
C0332290 (UMLS CUI [7,2])
C0036341 (UMLS CUI [7,3])
C0175636 (UMLS CUI [8,1])
C0332290 (UMLS CUI [8,2])
C0036341 (UMLS CUI [8,3])
C1549471 (UMLS CUI [9,1])
C0332290 (UMLS CUI [9,2])
C0036341 (UMLS CUI [9,3])
PANSS score
Item
a total positive and negative syndrome scale (panss) score between 60 and 120, inclusive, at screening and baseline
boolean
C0451383 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods
Item
female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study 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])
Investigational New Drugs Self Administration | Supplementation therapy Oral | Investigational New Drugs Administration Assistance
Item
be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study exclusion criteria:
boolean
C0013230 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C1735596 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C1269765 (UMLS CUI [3,3])
Exclusion Criteria | Axis I diagnosis Primary | Exception Schizophrenia
Item
a primary, active dsm-iv diagnosis on axis i other than schizophrenia
boolean
C0680251 (UMLS CUI [1])
C0270287 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0036341 (UMLS CUI [3,2])
Exclusion Criteria | PANSS score Decrease Percentage
Item
a decrease of at least 25 percent in the total panss score between screening and baseline
boolean
C0680251 (UMLS CUI [1])
C0451383 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Exclusion Criteria | Study Subject Participation Status
Item
participants who have previously participated in this study
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Exclusion Criteria | Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence
Item
a dsm-iv diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
boolean
C0680251 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
Exclusion Criteria | Treatment-resistant schizophrenia | Antipsychotic Agents Different Quantity | Antipsychotic Agents Maximum Tolerated Dose | Response failed
Item
history of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
boolean
C0680251 (UMLS CUI [1])
C3544321 (UMLS CUI [2])
C0040615 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0040615 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C1704632 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
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