ID

19341

Beschreibung

New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00161018

Link

https://clinicaltrials.gov/show/NCT00161018

Stichworte

Versionen (1)
  1. 19.12.16 19.12.16 -
Hochgeladen am

19. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00161018

Englisch

Eligibility Schizophrenia NCT00161018

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females, between ages 18 and 65 year sof age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
females of childbearing potential must agree to use medically accepted means of contraception.
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
a diagnosis of schizophrenia according to the dsm-iv.
Beschreibung

Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0036341
subjects must meet retrospective criteria for treatment-resistance as defined:
Beschreibung

Therapeutic procedure Resistance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1514892
1. persistent positive psychotic symptoms.
Beschreibung

Psychotic symptom Positive persistent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871189
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0205322
2. current presence of at least a moderately severe illness as rated by the total bprs.
Beschreibung

Illness Moderate Brief Psychiatric Rating Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0029941
3. persistence of illness- no evidence of good functioning in the last five years.
Beschreibung

Illness persistent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205322
4. drug-refectory condition defined as at least two periods of treatment in the preceding significant symptom relief.
Beschreibung

Condition Pharmaceutical Preparations refractory | Therapeutic procedure Quantity | Symptom relief Significant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0564405
UMLS CUI [3,3]
C0750502
subjects must been judged competent to consent by the esc evaluation and provide voluntary informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects must be reliable. they must agree to cooperate with all tests and examinations required by the protocol.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
patients msut have a normal ophthalmoscopic exam within 6 months of a full eye exam if any lense abnormality prior to entering study.
Beschreibung

Ophthalmoscopy Normal | complete examination of the eye | Abnormality of the lens

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029090
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0848987
UMLS CUI [3]
C0549651
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are either pregnant or lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within three months or death is anticipated with three years.
Beschreibung

Illness Serious Hospitalization Anticipated | Illness Serious Cessation of life Anticipated | Liver diseases | Kidney Diseases | gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Endocrine System Diseases | nervous system disorder | Immune System Diseases | Hematological Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0019993
UMLS CUI [1,4]
C3840775
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0011065
UMLS CUI [2,4]
C3840775
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5,1]
C0017163
UMLS CUI [5,2]
C0012634
UMLS CUI [6]
C0035204
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0021053
UMLS CUI [11]
C0018939
history of severe allergies or multiple adverse drug reactions.
Beschreibung

Drug Allergy Severe | Adverse reaction to drug multiple

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0041755
UMLS CUI [2,2]
C0439064
dsm-iv substance abuse or dependence within the past month.
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
any dsm-iv organic mental disorder.
Beschreibung

oeganic mental disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0029227
judged clinically to be at serious suicidal risk.
Beschreibung

At risk for suicide Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
definitive failure to show clinically significant response (improved in cgi score of at least 1 point) to and adequate trial of clozapine (600mg/day for at least 6 weeks)
Beschreibung

Clozapine Poor response to treatment Clinical Global Impression Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C1320680
UMLS CUI [1,3]
C3639708
uncontrolled seizures within the past 6 months.
Beschreibung

Seizures Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
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Ähnliche Modelle

Eligibility Schizophrenia NCT00161018

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females, between ages 18 and 65 year sof age.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must agree to use medically accepted means of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Schizophrenia
Item
a diagnosis of schizophrenia according to the dsm-iv.
boolean
C0036341 (UMLS CUI [1])
Therapeutic procedure Resistance
Item
subjects must meet retrospective criteria for treatment-resistance as defined:
boolean
C0087111 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Psychotic symptom Positive persistent
Item
1. persistent positive psychotic symptoms.
boolean
C0871189 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
Illness Moderate Brief Psychiatric Rating Scale
Item
2. current presence of at least a moderately severe illness as rated by the total bprs.
boolean
C0221423 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0029941 (UMLS CUI [1,3])
Illness persistent
Item
3. persistence of illness- no evidence of good functioning in the last five years.
boolean
C0221423 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Condition Pharmaceutical Preparations refractory | Therapeutic procedure Quantity | Symptom relief Significant
Item
4. drug-refectory condition defined as at least two periods of treatment in the preceding significant symptom relief.
boolean
C0348080 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0564405 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Informed Consent
Item
subjects must been judged competent to consent by the esc evaluation and provide voluntary informed consent.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
subjects must be reliable. they must agree to cooperate with all tests and examinations required by the protocol.
boolean
C0525058 (UMLS CUI [1])
Ophthalmoscopy Normal | complete examination of the eye | Abnormality of the lens
Item
patients msut have a normal ophthalmoscopic exam within 6 months of a full eye exam if any lense abnormality prior to entering study.
boolean
C0029090 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0848987 (UMLS CUI [2])
C0549651 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
females who are either pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Hospitalization Anticipated | Illness Serious Cessation of life Anticipated | Liver diseases | Kidney Diseases | gastroenterology Disease | Respiration Disorders | Cardiovascular Diseases | Endocrine System Diseases | nervous system disorder | Immune System Diseases | Hematological Disease
Item
serious medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within three months or death is anticipated with three years.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C3840775 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0011065 (UMLS CUI [2,3])
C3840775 (UMLS CUI [2,4])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0017163 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0035204 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0021053 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
Drug Allergy Severe | Adverse reaction to drug multiple
Item
history of severe allergies or multiple adverse drug reactions.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0041755 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
dsm-iv substance abuse or dependence within the past month.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
oeganic mental disorder
Item
any dsm-iv organic mental disorder.
boolean
C0029227 (UMLS CUI [1])
At risk for suicide Serious
Item
judged clinically to be at serious suicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Clozapine Poor response to treatment Clinical Global Impression Questionnaire
Item
definitive failure to show clinically significant response (improved in cgi score of at least 1 point) to and adequate trial of clozapine (600mg/day for at least 6 weeks)
boolean
C0009079 (UMLS CUI [1,1])
C1320680 (UMLS CUI [1,2])
C3639708 (UMLS CUI [1,3])
Seizures Uncontrolled
Item
uncontrolled seizures within the past 6 months.
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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