ID

32017

Beschrijving

Oxytocin Add on Study for Stable Schizophrenic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00506909

Link

https://clinicaltrials.gov/show/NCT00506909

Trefwoorden

Versies (1)
  1. 12-10-18 12-10-18 -
Houder van rechten

See clinicaltrials.gov

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12 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00506909

Engels

Eligibility Schizophrenia NCT00506909

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adult men or women, 18 years of age or older.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. meet dsm-iv criteria for schizophrenia.
Beschrijving

Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
3. women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
4. must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to clozapine olanzapine, risperidone, ziprasidone, aripiprazole, seroquel) with no major dose changes for at least 4 weeks.
Beschrijving

Atypical antipsychotic Dose Therapeutic | Clozapine | olanzapine | Risperidone | ziprasidone | aripiprazole | Seroquel | Dosage unchanged

Datatype

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0302350
UMLS CUI [2]
C0009079
UMLS CUI [3]
C0171023
UMLS CUI [4]
C0073393
UMLS CUI [5]
C0380393
UMLS CUI [6]
C0299792
UMLS CUI [7]
C0287163
UMLS CUI [8,1]
C0178602
UMLS CUI [8,2]
C0442739
5. a minimum panss total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the panss (suspiciousness/persecution) at screening.
Beschrijving

Positive and negative syndrome scale | PANSS - Suspiciousness or Persecution

Datatype

boolean

Alias
UMLS CUI [1]
C0451383
UMLS CUI [2]
C4087067
6. have a clinical global impressions-severity (cgi-s) scale score of at least 4 (moderately ill) at baseline.
Beschrijving

Clinical global impression scale

Datatype

boolean

Alias
UMLS CUI [1]
C3639708
7. must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
Beschrijving

Able to communicate Research Personnel | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C0021430
8. must be able to use nasal spray.
Beschrijving

Use of Nasal Spray

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0461725
9. must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects will be excluded from the study of they meet any of the following criteria:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. are pregnant or are breastfeeding (negative pregnancy test at screening).
Beschrijving

Pregnancy | Breast Feeding | Pregnancy test negative Screening

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0427780
UMLS CUI [3,2]
C1710032
2. a urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
Beschrijving

Drug abuse Urine drug screen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013146
UMLS CUI [1,2]
C0202274
3. any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
Beschrijving

Medical condition Interferes with Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
4. are unsuitable in any way to participate in this study, in the opinion of the investigator.
Beschrijving

Study Subject Participation Status Inappropriate

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
5. another current dsm-iv diagnosis other than schizophrenia.
Beschrijving

DSM-IV Diagnosis | Exception Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220952
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
permitted:
Beschrijving

allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0683607
subjects on one ssri, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.
Beschrijving

SSRI Quantity | Taking medication to help sleep Dose Adequate | Diphenhydramine | zolpidem | zaleplon | Diazepam

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2054158
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205411
UMLS CUI [3]
C0012522
UMLS CUI [4]
C0078839
UMLS CUI [5]
C0251504
UMLS CUI [6]
C0012010
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Similar models

Eligibility Schizophrenia NCT00506909

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. adult men or women, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
2. meet dsm-iv criteria for schizophrenia.
boolean
C0036341 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
3. women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Atypical antipsychotic Dose Therapeutic | Clozapine | olanzapine | Risperidone | ziprasidone | aripiprazole | Seroquel | Dosage unchanged
Item
4. must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to clozapine olanzapine, risperidone, ziprasidone, aripiprazole, seroquel) with no major dose changes for at least 4 weeks.
boolean
C1276996 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0009079 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
C0073393 (UMLS CUI [4])
C0380393 (UMLS CUI [5])
C0299792 (UMLS CUI [6])
C0287163 (UMLS CUI [7])
C0178602 (UMLS CUI [8,1])
C0442739 (UMLS CUI [8,2])
Positive and negative syndrome scale | PANSS - Suspiciousness or Persecution
Item
5. a minimum panss total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the panss (suspiciousness/persecution) at screening.
boolean
C0451383 (UMLS CUI [1])
C4087067 (UMLS CUI [2])
Clinical global impression scale
Item
6. have a clinical global impressions-severity (cgi-s) scale score of at least 4 (moderately ill) at baseline.
boolean
C3639708 (UMLS CUI [1])
Able to communicate Research Personnel | Informed Consent
Item
7. must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Use of Nasal Spray
Item
8. must be able to use nasal spray.
boolean
C1524063 (UMLS CUI [1,1])
C0461725 (UMLS CUI [1,2])
Protocol Compliance
Item
9. must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
subjects will be excluded from the study of they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy test negative Screening
Item
1. are pregnant or are breastfeeding (negative pregnancy test at screening).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0427780 (UMLS CUI [3,1])
C1710032 (UMLS CUI [3,2])
Drug abuse Urine drug screen
Item
2. a urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
boolean
C0013146 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Medical condition Interferes with Study Protocol
Item
3. any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Study Subject Participation Status Inappropriate
Item
4. are unsuitable in any way to participate in this study, in the opinion of the investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
DSM-IV Diagnosis | Exception Schizophrenia
Item
5. another current dsm-iv diagnosis other than schizophrenia.
boolean
C0220952 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
allowed
Item
permitted:
boolean
C0683607 (UMLS CUI [1])
SSRI Quantity | Taking medication to help sleep Dose Adequate | Diphenhydramine | zolpidem | zaleplon | Diazepam
Item
subjects on one ssri, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.
boolean
C0360105 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2054158 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0012522 (UMLS CUI [3])
C0078839 (UMLS CUI [4])
C0251504 (UMLS CUI [5])
C0012010 (UMLS CUI [6])
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