ID

32104

Beschrijving

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00731549

Link

https://clinicaltrials.gov/show/NCT00731549

Trefwoorden

Versies (1)
  1. 17-10-18 17-10-18 -
Houder van rechten

See clinicaltrials.gov

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17 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00731549

Engels

Eligibility Schizophrenia NCT00731549

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by irb/iec), prior to the initiation of any protocol-required procedures.
Beschrijving

Informed Consent | Informed Consent Patient Representatives

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subjects who complete studies 246/247 or who withdrew from the double-blind maintenance phase of either study (phase 4 of study 246 or phase 3 of study 247), or new subjects not participating in studies 246/247.
Beschrijving

Clinical Trials Specified Completed | Patient withdrawn from trial specified | Study Subject New | Participation Absent Clinical Trials Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0205369
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0205314
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0008976
UMLS CUI [4,4]
C0205369
# subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
Beschrijving

Patient need for Antipsychotic Agents chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0040615
UMLS CUI [1,3]
C0205191
subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, im depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
Beschrijving

Comprehension Study Protocol | Protocol Compliance | Depot Preparations Intramuscular injection | Illicit Drugs Discontinuation | Rating scale Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C0086129
UMLS CUI [3,2]
C0021492
UMLS CUI [4,1]
C0086190
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C0681889
UMLS CUI [5,2]
C1516048
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with a current dsm-iv-tr diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
Beschrijving

Mental disorders | Exception Schizophrenia | Schizoaffective Disorder | Major Depressive Disorder | Bipolar Disorder | Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Borderline Personality Disorder | Paranoid Personality Disorder | Histrionic Personality Disorder | Schizotypal Personality Disorder | Schizoid Personality Disorder | Antisocial Personality Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C1269683
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0011206
UMLS CUI [7]
C0497327
UMLS CUI [8]
C0002625
UMLS CUI [9]
C0009241
UMLS CUI [10]
C0006012
UMLS CUI [11]
C0030477
UMLS CUI [12]
C0019681
UMLS CUI [13]
C0036363
UMLS CUI [14]
C0036339
UMLS CUI [15]
C0003431
subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
Beschrijving

Schizophrenia Resistant to Antipsychotic Agents | Schizophrenia Antipsychotic Agents Refractory | Clozapine Response

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0040615
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C0040615
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0009079
UMLS CUI [3,2]
C1704632
subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
Beschrijving

At risk Violent behavior | At risk for suicide

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0424323
UMLS CUI [2]
C0563664
subjects who currently meet dsm-iv-tr criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
Beschrijving

Substance Dependence | Benzodiazepines | Exception Caffeine dependence | Exception Nicotine Dependence | DRUG SCREEN COCAINE POSITIVE Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0005064
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028043
UMLS CUI [5,1]
C0743294
UMLS CUI [5,2]
C1265611
subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
Beschrijving

Hypersensitivity Aripiprazole | Intolerance to Aripiprazole | Aripiprazole Unresponsive to Treatment | Hypersensitivity Quinolones | Intolerance to Quinolones | Quinolones Unresponsive to Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0299792
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0299792
UMLS CUI [3,1]
C0299792
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0034428
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0034428
UMLS CUI [6,1]
C0034428
UMLS CUI [6,2]
C0205269
subjects with a history of hypersensitivity to antipsychotic agents.
Beschrijving

Hypersensitivity Antipsychotic Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0040615
subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Beschrijving

Neuroleptic Malignant Syndrome | Tardive Dyskinesia

Datatype

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0686347
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Similar models

Eligibility Schizophrenia NCT00731549

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Patient Representatives
Item
subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by irb/iec), prior to the initiation of any protocol-required procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Age
Item
male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Clinical Trials Specified Completed | Patient withdrawn from trial specified | Study Subject New | Participation Absent Clinical Trials Specified
Item
subjects who complete studies 246/247 or who withdrew from the double-blind maintenance phase of either study (phase 4 of study 246 or phase 3 of study 247), or new subjects not participating in studies 246/247.
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0422727 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0681850 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0679823 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0205369 (UMLS CUI [4,4])
Patient need for Antipsychotic Agents chronic
Item
# subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
boolean
C0686904 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
Comprehension Study Protocol | Protocol Compliance | Depot Preparations Intramuscular injection | Illicit Drugs Discontinuation | Rating scale Assessment
Item
subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, im depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
C0086129 (UMLS CUI [3,1])
C0021492 (UMLS CUI [3,2])
C0086190 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0681889 (UMLS CUI [5,1])
C1516048 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Exception Schizophrenia | Schizoaffective Disorder | Major Depressive Disorder | Bipolar Disorder | Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Borderline Personality Disorder | Paranoid Personality Disorder | Histrionic Personality Disorder | Schizotypal Personality Disorder | Schizoid Personality Disorder | Antisocial Personality Disorder
Item
subjects with a current dsm-iv-tr diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0011206 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0002625 (UMLS CUI [8])
C0009241 (UMLS CUI [9])
C0006012 (UMLS CUI [10])
C0030477 (UMLS CUI [11])
C0019681 (UMLS CUI [12])
C0036363 (UMLS CUI [13])
C0036339 (UMLS CUI [14])
C0003431 (UMLS CUI [15])
Schizophrenia Resistant to Antipsychotic Agents | Schizophrenia Antipsychotic Agents Refractory | Clozapine Response
Item
subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
boolean
C0036341 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0040615 (UMLS CUI [1,3])
C0036341 (UMLS CUI [2,1])
C0040615 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0009079 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
At risk Violent behavior | At risk for suicide
Item
subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
boolean
C1444641 (UMLS CUI [1,1])
C0424323 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2])
Substance Dependence | Benzodiazepines | Exception Caffeine dependence | Exception Nicotine Dependence | DRUG SCREEN COCAINE POSITIVE Quantity
Item
subjects who currently meet dsm-iv-tr criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
boolean
C0038580 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
C0743294 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Hypersensitivity Aripiprazole | Intolerance to Aripiprazole | Aripiprazole Unresponsive to Treatment | Hypersensitivity Quinolones | Intolerance to Quinolones | Quinolones Unresponsive to Treatment
Item
subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
boolean
C0020517 (UMLS CUI [1,1])
C0299792 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C0299792 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0034428 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0034428 (UMLS CUI [5,2])
C0034428 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
Hypersensitivity Antipsychotic Agents
Item
subjects with a history of hypersensitivity to antipsychotic agents.
boolean
C0020517 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
Neuroleptic Malignant Syndrome | Tardive Dyskinesia
Item
subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
boolean
C0027849 (UMLS CUI [1])
C0686347 (UMLS CUI [2])
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