ID

23089

Beskrivning

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00712270

Länk

https://clinicaltrials.gov/show/NCT00712270

Nyckelord

Versioner (1)
  1. 2017-06-23 2017-06-23 -
Uppladdad den

23 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00712270

Engelsk

Eligibility Schizophrenia NCT00712270

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects will meet dsm-iv diagnostic criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or (non-affective) psychotic disorder, nos. subjects with schizophreniform disorder or psychotic disorder, nos, will be diagnostically reevaluated (recontacted if no longer involved in the study) after a minimum of six months of psychotic symptoms in order to determine whether diagnostic criteria for schizophrenia or schizoaffective disorder have been met.
Beskrivning

Schizophreniform Disorders | Schizophrenia | Schizoaffective Disorder | Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0036358
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0033975
2. subjects will be between 18 and 55 years of age, inclusive.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. subjects will be able to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
Beskrivning

Informed Consent | Informed Consent Legal Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
4. present score on at least one panss psychosis items (p1, p2, p3, p5 or p6) > 4(moderately severe) and cgi severity score > 4 (moderate).
Beskrivning

Positive and negative syndrome scale | Psychotic Disorder Moderate | Psychotic Disorder Severe | Clinical Global Impression Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C0451383
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C3639708
5. female patients of childbearing potential must be using a medically accepted means of contraception
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current active substance use disorder diagnosis or a history of cocaine abuse or dependence;
Beskrivning

Substance Use Disorders | Cocaine Abuse | Cocaine Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0009171
UMLS CUI [3]
C0600427
2. female patients who are either pregnant or nursing;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. known history of mental retardation, seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
Beskrivning

Mental Retardation | Epilepsy | Craniocerebral Trauma | Prolonged loss of consciousness | neurologic sequelae | Brain Injury structural

Datatyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0018674
UMLS CUI [4]
C0234433
UMLS CUI [5]
C0746864
UMLS CUI [6,1]
C0270611
UMLS CUI [6,2]
C0678594
4. non-english speaking (mastery of english insufficient to participate in study evaluation procedures);
Beskrivning

Able to speak English Language Insufficient | Participation Evaluation procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0231180
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1261322
5. serious, unstable medical illness;
Beskrivning

Illness Serious Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
6. known hypersensitivity to any study medication;
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
7. medical contraindication to any element of the study procedure;
Beskrivning

Medical contraindication Study Element

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3812827
8. current symptoms which present serious risk of danger to self or others;
Beskrivning

Symptoms DANGER OF HARM TO SELF Risk Serious | Symptoms High risk of harm to others

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0149660
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0205404
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1320315
9. participation in a clinical trial of an investigational drug within 30 days of study entry;
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
10. current severity of psychiatric symptoms contraindicates a delay in initiation of antipsychotic medication treatment until functional imaging studies and neuropsychological testing have been completed;
Beskrivning

Psychiatric symptom Severity | Medical contraindication Delay Antipsychotic drug therapy | Functional Imaging | Neuropsychological Tests

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233401
UMLS CUI [1,2]
C0392364
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0205421
UMLS CUI [2,3]
C1319421
UMLS CUI [3]
C1517324
UMLS CUI [4]
C0027902
11. baseline qtc interval of > 450 msec.
Beskrivning

QTc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C2216079
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Similar models

Eligibility Schizophrenia NCT00712270

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophreniform Disorders | Schizophrenia | Schizoaffective Disorder | Psychotic Disorders
Item
1. subjects will meet dsm-iv diagnostic criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or (non-affective) psychotic disorder, nos. subjects with schizophreniform disorder or psychotic disorder, nos, will be diagnostically reevaluated (recontacted if no longer involved in the study) after a minimum of six months of psychotic symptoms in order to determine whether diagnostic criteria for schizophrenia or schizoaffective disorder have been met.
boolean
C0036358 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
Age
Item
2. subjects will be between 18 and 55 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
3. subjects will be able to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Positive and negative syndrome scale | Psychotic Disorder Moderate | Psychotic Disorder Severe | Clinical Global Impression Questionnaire
Item
4. present score on at least one panss psychosis items (p1, p2, p3, p5 or p6) > 4(moderately severe) and cgi severity score > 4 (moderate).
boolean
C0451383 (UMLS CUI [1])
C0033975 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C3639708 (UMLS CUI [4])
Childbearing Potential Contraceptive methods
Item
5. female patients of childbearing potential must be using a medically accepted means of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Cocaine Abuse | Cocaine Dependence
Item
1. current active substance use disorder diagnosis or a history of cocaine abuse or dependence;
boolean
C0038586 (UMLS CUI [1])
C0009171 (UMLS CUI [2])
C0600427 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
2. female patients who are either pregnant or nursing;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental Retardation | Epilepsy | Craniocerebral Trauma | Prolonged loss of consciousness | neurologic sequelae | Brain Injury structural
Item
3. known history of mental retardation, seizure disorder, or a clinically significant head injury (prolonged loss of consciousness, neurological sequelae, or demonstrated structural brain injury);
boolean
C0025362 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0018674 (UMLS CUI [3])
C0234433 (UMLS CUI [4])
C0746864 (UMLS CUI [5])
C0270611 (UMLS CUI [6,1])
C0678594 (UMLS CUI [6,2])
Able to speak English Language Insufficient | Participation Evaluation procedure
Item
4. non-english speaking (mastery of english insufficient to participate in study evaluation procedures);
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Illness Serious Unstable
Item
5. serious, unstable medical illness;
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
6. known hypersensitivity to any study medication;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Medical contraindication Study Element
Item
7. medical contraindication to any element of the study procedure;
boolean
C1301624 (UMLS CUI [1,1])
C3812827 (UMLS CUI [1,2])
Symptoms DANGER OF HARM TO SELF Risk Serious | Symptoms High risk of harm to others
Item
8. current symptoms which present serious risk of danger to self or others;
boolean
C1457887 (UMLS CUI [1,1])
C0149660 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2,1])
C1320315 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
9. participation in a clinical trial of an investigational drug within 30 days of study entry;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Psychiatric symptom Severity | Medical contraindication Delay Antipsychotic drug therapy | Functional Imaging | Neuropsychological Tests
Item
10. current severity of psychiatric symptoms contraindicates a delay in initiation of antipsychotic medication treatment until functional imaging studies and neuropsychological testing have been completed;
boolean
C0233401 (UMLS CUI [1,1])
C0392364 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
C1319421 (UMLS CUI [2,3])
C1517324 (UMLS CUI [3])
C0027902 (UMLS CUI [4])
QTc interval
Item
11. baseline qtc interval of > 450 msec.
boolean
C2216079 (UMLS CUI [1])
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