ID

25315

Beschrijving

A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00645099

Link

https://clinicaltrials.gov/show/NCT00645099

Trefwoorden

Versies (1)
  1. 01-09-17 01-09-17 -
Geüploaded op

1 september 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00645099

Engels

Eligibility Schizophrenia NCT00645099

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient meets the dsm-iv criteria for schizophrenia
Beschrijving

Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
patient has a panss total score at screening of 60 to 100, inclusive
Beschrijving

Positive and negative syndrome scale

Datatype

boolean

Alias
UMLS CUI [1]
C0451383
patient must, in the opinion of the investigator, benefit from treatment with paliperidone er or olanzapine
Beschrijving

Benefits Due to Paliperidone | Benefits Due to Olanzapine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086387
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0753678
UMLS CUI [2,1]
C0086387
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0171023
patients on lipid-lowering therapy must be on a stable dose for at least 4 weeks for statins, niacin, ezetimibe and resins or for at least 12 weeks for fibrates
Beschrijving

Lipid-lowering therapy | Statins Dose Stable | Niacin Dose Stable | Ezetimibe Dose Stable | Fibrates Dose Stable

Datatype

boolean

Alias
UMLS CUI [1]
C0585943
UMLS CUI [2,1]
C0360714
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0027996
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1142985
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C1449704
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
female patients must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
Beschrijving

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive Patch | Partner Male sterilization

Datatype

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]
C0009905
UMLS CUI [6]
C1656586
UMLS CUI [7]
C0021900
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C2985284
UMLS CUI [10,1]
C0682323
UMLS CUI [10,2]
C0024559
women of child-bearing potential must have a negative urine pregnancy test at screening
Beschrijving

Childbearing Potential Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
patient is healthy on the basis of a physical examination and vital signs at screening
Beschrijving

Healthy Physical Examination | Healthy Vital signs

Datatype

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0518766
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has previously been treated with paliperidone er, olanzapine, or clozapine within the past 6 months or has never been treated with an antipsychotic before
Beschrijving

paliperidone | olanzapine | Clozapine | Antipsychotic Agents Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0753678
UMLS CUI [2]
C0171023
UMLS CUI [3]
C0009079
UMLS CUI [4,1]
C0040615
UMLS CUI [4,2]
C0332197
treatment with a depot antipsychotic within the past 3 months
Beschrijving

Depot antipsychotic agent

Datatype

boolean

Alias
UMLS CUI [1]
C2585377
treatment with a mood stabilizer or a recently initiated antidepressant (<= 3 months)
Beschrijving

Mood Stabilizers | Antidepressive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C4020582
UMLS CUI [2]
C0003289
patient has abnormal fasting plasma glucose (> 126 mg/dl) or fasting triglycerides (tg) levels (> 400 mg/dl) at screening
Beschrijving

Elevated fasting plasma glucose | Elevated fasting triglycerides

Datatype

boolean

Alias
UMLS CUI [1]
C4228506
UMLS CUI [2]
C2874288
relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator)
Beschrijving

Cardiovascular Diseases | Respiration Disorders | nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | LABORATORY ABNORMALITIES

Datatype

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]
C0014130
UMLS CUI [9]
C0021053
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0035204
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C0027765
UMLS CUI [12,2]
C0443343
UMLS CUI [13,1]
C0036572
UMLS CUI [13,2]
C0443343
UMLS CUI [14,1]
C0007820
UMLS CUI [14,2]
C0443343
UMLS CUI [15,1]
C0022658
UMLS CUI [15,2]
C0443343
UMLS CUI [16,1]
C0023895
UMLS CUI [16,2]
C0443343
UMLS CUI [17,1]
C0014130
UMLS CUI [17,2]
C0443343
UMLS CUI [18,1]
C0021053
UMLS CUI [18,2]
C0443343
UMLS CUI [19]
C1853129
history or current symptoms of tardive dyskinesia
Beschrijving

Tardive Dyskinesia Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686347
UMLS CUI [1,2]
C1457887
history of neuroleptic malignant syndrome
Beschrijving

Neuroleptic Malignant Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0027849
pregnant or breast-feeding female
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Eligibility Schizophrenia NCT00645099

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patient meets the dsm-iv criteria for schizophrenia
boolean
C0036341 (UMLS CUI [1])
Positive and negative syndrome scale
Item
patient has a panss total score at screening of 60 to 100, inclusive
boolean
C0451383 (UMLS CUI [1])
Benefits Due to Paliperidone | Benefits Due to Olanzapine
Item
patient must, in the opinion of the investigator, benefit from treatment with paliperidone er or olanzapine
boolean
C0086387 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0753678 (UMLS CUI [1,3])
C0086387 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0171023 (UMLS CUI [2,3])
Lipid-lowering therapy | Statins Dose Stable | Niacin Dose Stable | Ezetimibe Dose Stable | Fibrates Dose Stable
Item
patients on lipid-lowering therapy must be on a stable dose for at least 4 weeks for statins, niacin, ezetimibe and resins or for at least 12 weeks for fibrates
boolean
C0585943 (UMLS CUI [1])
C0360714 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0027996 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1142985 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C1449704 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Contraceptive injection | Intrauterine Devices | Barrier Contraception Double | Contraceptive Patch | Partner Male sterilization
Item
female patients must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) 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])
C0009905 (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])
C0682323 (UMLS CUI [10,1])
C0024559 (UMLS CUI [10,2])
Childbearing Potential Urine pregnancy test negative
Item
women of child-bearing potential must have a negative urine pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Healthy Physical Examination | Healthy Vital signs
Item
patient is healthy on the basis of a physical examination and vital signs at screening
boolean
C3898900 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0518766 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
paliperidone | olanzapine | Clozapine | Antipsychotic Agents Absent
Item
patient has previously been treated with paliperidone er, olanzapine, or clozapine within the past 6 months or has never been treated with an antipsychotic before
boolean
C0753678 (UMLS CUI [1])
C0171023 (UMLS CUI [2])
C0009079 (UMLS CUI [3])
C0040615 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Depot antipsychotic agent
Item
treatment with a depot antipsychotic within the past 3 months
boolean
C2585377 (UMLS CUI [1])
Mood Stabilizers | Antidepressive Agents
Item
treatment with a mood stabilizer or a recently initiated antidepressant (<= 3 months)
boolean
C4020582 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
Elevated fasting plasma glucose | Elevated fasting triglycerides
Item
patient has abnormal fasting plasma glucose (> 126 mg/dl) or fasting triglycerides (tg) levels (> 400 mg/dl) at screening
boolean
C4228506 (UMLS CUI [1])
C2874288 (UMLS CUI [2])
Cardiovascular Diseases | Respiration Disorders | nervous system disorder | Seizures | Cerebrovascular Disorders | Kidney Diseases | Liver diseases | Endocrine System Diseases | Immune System Diseases | Cardiovascular Diseases Unstable | Respiration Disorders Unstable | Nervous system disorder Unstable | Seizures Unstable | Cerebrovascular Disorders Unstable | Kidney Diseases Unstable | Liver diseases Unstable | Endocrine System Diseases Unstable | Immune System Diseases Unstable | LABORATORY ABNORMALITIES
Item
relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator)
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])
C0014130 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0007222 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0035204 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C0027765 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
C0036572 (UMLS CUI [13,1])
C0443343 (UMLS CUI [13,2])
C0007820 (UMLS CUI [14,1])
C0443343 (UMLS CUI [14,2])
C0022658 (UMLS CUI [15,1])
C0443343 (UMLS CUI [15,2])
C0023895 (UMLS CUI [16,1])
C0443343 (UMLS CUI [16,2])
C0014130 (UMLS CUI [17,1])
C0443343 (UMLS CUI [17,2])
C0021053 (UMLS CUI [18,1])
C0443343 (UMLS CUI [18,2])
C1853129 (UMLS CUI [19])
Tardive Dyskinesia Symptoms
Item
history or current symptoms of tardive dyskinesia
boolean
C0686347 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Neuroleptic Malignant Syndrome
Item
history of neuroleptic malignant syndrome
boolean
C0027849 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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