ID

32032

Descripción

Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00589914

Link

https://clinicaltrials.gov/show/NCT00589914

Palabras clave

Versiones (1)
  1. 15/10/18 15/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00589914

Inglés

Eligibility Schizophrenia NCT00589914

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet diagnostic criteria for schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria as specified by the protocol for at least 1 year before screening
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
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
Descripción

Medical Records Consistent with Schizophrenia | Documentation Consistent with Schizophrenia | Verbal information Consistent with Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025102
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0036341
UMLS CUI [2,1]
C0175636
UMLS CUI [2,2]
C0332290
UMLS CUI [2,3]
C0036341
UMLS CUI [3,1]
C1549471
UMLS CUI [3,2]
C0332290
UMLS CUI [3,3]
C0036341
a total panss score between 60 and 120, inclusive, at screening and baseline; body mass index (bmi) at the screening visit bmi at least 17 kg/m2
Descripción

PANSS | Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2]
C1305855
female patients 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 as specified by the protocol. women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hcg) pregnancy test result at screening.
Descripción

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Tipo de datos

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 [5,1]
C3831118
UMLS CUI [5,2]
C0430060
UMLS CUI [5,3]
C1513916
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient unable to provide consent or involuntarily committed to psychiatric hospitalization; a primary, active dsm-iv diagnosis on axis i other than schizophrenia
Descripción

Informed Consent Unable | Psychiatric hospitalization Involuntary | Axis I diagnosis Primary | Exception Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0748061
UMLS CUI [2,2]
C2986385
UMLS CUI [3,1]
C0270287
UMLS CUI [3,2]
C0205225
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0036341
a dsm-iv diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
Descripción

Substance Dependence | Exception Nicotine Dependence | Exception Caffeine dependence

Tipo de datos

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
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)
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3544321
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C1705242
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0231175
relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; history of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
Descripción

Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Hematological Disease | Endocrine System Diseases | Immune System Diseases | Systemic disease | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Systemic disease Unstable | Neuroleptic Malignant Syndrome | Gastrointestinal stenosis Severe Pre-existing | Lacking Able to swallow Oral medication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0018939
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0021053
UMLS CUI [11]
C0442893
UMLS CUI [12,1]
C0007222
UMLS CUI [12,2]
C0443343
UMLS CUI [13,1]
C0035204
UMLS CUI [13,2]
C0443343
UMLS CUI [14,1]
C0027765
UMLS CUI [14,2]
C0443343
UMLS CUI [15,1]
C0036572
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0007820
UMLS CUI [16,2]
C0443343
UMLS CUI [17,1]
C0022658
UMLS CUI [17,2]
C0443343
UMLS CUI [18,1]
C0023895
UMLS CUI [18,2]
C0443343
UMLS CUI [19,1]
C0018939
UMLS CUI [19,2]
C0443343
UMLS CUI [20,1]
C0014130
UMLS CUI [20,2]
C0443343
UMLS CUI [21,1]
C0021053
UMLS CUI [21,2]
C0443343
UMLS CUI [22,1]
C0442893
UMLS CUI [22,2]
C0443343
UMLS CUI [23]
C0027849
UMLS CUI [24,1]
C0521587
UMLS CUI [24,2]
C0205082
UMLS CUI [24,3]
C2347662
UMLS CUI [25,1]
C0332268
UMLS CUI [25,2]
C2712086
UMLS CUI [25,3]
C0175795
significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; history of life-threatening allergic reaction to any drug; known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
Descripción

At risk for suicide | At risk Physical aggression | Drug Allergy Life Threatening | Risperidone allergy | Hypersensitivity Paliperidone | Hypersensitivity Intralipid Percentage | Intolerance to Risperidone | Intolerance to Paliperidone | Intolerance to Intralipid Percentage | Hypersensitivity Soybean Oil | Allergy to egg yolks | Hypersensitivity Phospholipids | Glycerol allergy | Intolerance to Soybean Oil | Intolerance to Egg Yolks | Intolerance to Phospholipids | Intolerance to Glycerol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0424323
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C2826244
UMLS CUI [4]
C0570837
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0753678
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0733854
UMLS CUI [6,3]
C0439165
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0073393
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0753678
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C0733854
UMLS CUI [9,3]
C0439165
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0037732
UMLS CUI [11]
C3468092
UMLS CUI [12,1]
C0020517
UMLS CUI [12,2]
C0031676
UMLS CUI [13]
C0571234
UMLS CUI [14,1]
C1744706
UMLS CUI [14,2]
C0037732
UMLS CUI [15,1]
C1744706
UMLS CUI [15,2]
C0013707
UMLS CUI [16,1]
C1744706
UMLS CUI [16,2]
C0031676
UMLS CUI [17,1]
C1744706
UMLS CUI [17,2]
C0017861
have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; history of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
Descripción

Investigational New Drugs | Biological agents Investigational | Investigational Medical Device | Malignant Neoplasms | Exception Basal cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C1517586
UMLS CUI [3]
C2346570
UMLS CUI [4]
C0006826
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
women who are pregnant or breast-feeding or are planning to become pregnant uring the study
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de datos

boolean

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

Eligibility Schizophrenia NCT00589914

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
meet diagnostic criteria for schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria as specified by the protocol for at least 1 year before screening
boolean
C0036341 (UMLS CUI [1])
Medical Records Consistent with Schizophrenia | Documentation Consistent with Schizophrenia | Verbal information Consistent with Schizophrenia
Item
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
C0025102 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
C0175636 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0036341 (UMLS CUI [2,3])
C1549471 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0036341 (UMLS CUI [3,3])
PANSS | Body mass index
Item
a total panss score between 60 and 120, inclusive, at screening and baseline; body mass index (bmi) at the screening visit bmi at least 17 kg/m2
boolean
C4086747 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
female patients 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 as specified by the protocol. women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hcg) pregnancy test result 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])
C3831118 (UMLS CUI [5,1])
C0430060 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Psychiatric hospitalization Involuntary | Axis I diagnosis Primary | Exception Schizophrenia
Item
patient unable to provide consent or involuntarily committed to psychiatric hospitalization; a primary, active dsm-iv diagnosis on axis i other than schizophrenia
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0748061 (UMLS CUI [2,1])
C2986385 (UMLS CUI [2,2])
C0270287 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0036341 (UMLS CUI [4,2])
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
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
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
C3544321 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
Cardiovascular Diseases | Respiration Disorders | Nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Hematological Disease | Endocrine System Diseases | Immune System Diseases | Systemic disease | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Hematological Disease Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | Systemic disease Unstable | Neuroleptic Malignant Syndrome | Gastrointestinal stenosis Severe Pre-existing | Lacking Able to swallow Oral medication
Item
relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; history of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0021053 (UMLS CUI [10])
C0442893 (UMLS CUI [11])
C0007222 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0035204 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0027765 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0036572 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0007820 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0022658 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0023895 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C0018939 (UMLS CUI [19,1])
C0443343 (UMLS CUI [19,2])
C0014130 (UMLS CUI [20,1])
C0443343 (UMLS CUI [20,2])
C0021053 (UMLS CUI [21,1])
C0443343 (UMLS CUI [21,2])
C0442893 (UMLS CUI [22,1])
C0443343 (UMLS CUI [22,2])
C0027849 (UMLS CUI [23])
C0521587 (UMLS CUI [24,1])
C0205082 (UMLS CUI [24,2])
C2347662 (UMLS CUI [24,3])
C0332268 (UMLS CUI [25,1])
C2712086 (UMLS CUI [25,2])
C0175795 (UMLS CUI [25,3])
At risk for suicide | At risk Physical aggression | Drug Allergy Life Threatening | Risperidone allergy | Hypersensitivity Paliperidone | Hypersensitivity Intralipid Percentage | Intolerance to Risperidone | Intolerance to Paliperidone | Intolerance to Intralipid Percentage | Hypersensitivity Soybean Oil | Allergy to egg yolks | Hypersensitivity Phospholipids | Glycerol allergy | Intolerance to Soybean Oil | Intolerance to Egg Yolks | Intolerance to Phospholipids | Intolerance to Glycerol
Item
significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; history of life-threatening allergic reaction to any drug; known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0424323 (UMLS CUI [2,2])
C0013182 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0570837 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0753678 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0733854 (UMLS CUI [6,2])
C0439165 (UMLS CUI [6,3])
C1744706 (UMLS CUI [7,1])
C0073393 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0753678 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0733854 (UMLS CUI [9,2])
C0439165 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0037732 (UMLS CUI [10,2])
C3468092 (UMLS CUI [11])
C0020517 (UMLS CUI [12,1])
C0031676 (UMLS CUI [12,2])
C0571234 (UMLS CUI [13])
C1744706 (UMLS CUI [14,1])
C0037732 (UMLS CUI [14,2])
C1744706 (UMLS CUI [15,1])
C0013707 (UMLS CUI [15,2])
C1744706 (UMLS CUI [16,1])
C0031676 (UMLS CUI [16,2])
C1744706 (UMLS CUI [17,1])
C0017861 (UMLS CUI [17,2])
Investigational New Drugs | Biological agents Investigational | Investigational Medical Device | Malignant Neoplasms | Exception Basal cell carcinoma
Item
have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; history of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
boolean
C0013230 (UMLS CUI [1])
C0005515 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast-feeding or are planning to become pregnant uring the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
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