ID

32083

Description

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00706654

Lien

https://clinicaltrials.gov/show/NCT00706654

Mots-clés

Versions (1)
  1. 17/10/2018 17/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

17 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00706654

Anglais

Eligibility Schizophrenia NCT00706654

1 Formulaires  
Inclusion Criteria
Description

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 required by institutional review board/independent ethics committee [irb/iec]), prior to the initiation of any protocol-required procedures.
Description

Informed Consent | Informed Consent Patient Representatives

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
male and female subjects 18 to 60 years of age, inclusive, at time of informed consent.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
subjects with a current diagnosis of schizophrenia as defined by diagnostic and statistical manual of mental disorders, version 4, text revision (dsm-iv-tr) criteria and a history of the illness for at least 3 years prior to screening.
Description

Schizophrenia Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
subjects who, in the investigator's judgment, require chronic treatment with an anti-psychotic medication.
Description

Patient need for Antipsychotic Agents chronic

Type de données

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 outcome measures, and who can be reliably rated on assessment scales.
Description

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

Type de données

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
Description

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.
Description

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

Type de données

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.
Description

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

Type de données

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.
Description

At risk Violent behavior | At risk for suicide

Type de données

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 2 positive drug screens for cocaine.
Description

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

Type de données

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, or hypersensitivity to anti-psychotic agents, including aripiprazole.
Description

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

Type de données

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
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0040615
subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Description

Neuroleptic Malignant Syndrome | Tardive Dyskinesia

Type de données

boolean

Alias
UMLS CUI [1]
C0027849
UMLS CUI [2]
C0686347
subjects with uncontrolled thyroid function abnormalities.
Description

Abnormal thyroid function Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0857576
UMLS CUI [1,2]
C0205318
subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments.
Description

Seizures | Neuroleptic Malignant Syndrome | Tardive Dyskinesia | Other medical condition At risk Patients | Other medical condition Interferes with Evaluation

Type de données

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0027849
UMLS CUI [3]
C0686347
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0030705
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
subjects who are involuntarily incarcerated.
Description

Incarcerated Involuntary

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392751
UMLS CUI [1,2]
C2986385
subjects who have undergone electroconvulsive therapy within 180 days of entry into phase 2.
Description

Electroconvulsive Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0013806
subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole im depot.
Description

Investigational New Drugs | Study Subject Participation Status | Aripiprazole Depot Preparation Intramuscular injection

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0299792
UMLS CUI [3,2]
C0086129
UMLS CUI [3,3]
C0021492
subjects with clinically significant abnormalities in laboratory test results, vital signs, or ecg results.
Description

Laboratory test result abnormal | Abnormal vital signs | ECG abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0277804
UMLS CUI [3]
C0522055
subjects hospitalized for more than 30 days in the 90 days prior to phase 1 (or phase 2 for subjects bypassing phase 1).
Description

Hospital stay duration

Type de données

boolean

Alias
UMLS CUI [1]
C4019086
subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam).
Description

Benzodiazepines Quantity | Lorazepam | Oxazepam

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0024002
UMLS CUI [3]
C0029997
subjects who fail to wash-out from prohibited concomitant medications, including the use of cyp2d6 or cyp3a4 inhibitors or cyp3a4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [maoi]), and mood stabilizers, during screening and phase 1.
Description

Illicit Drugs Washout failed | CYP2D6 Inhibitors | CYP3A4 Inhibitors | CYP3A4 Inducers | Antipsychotic Agents | Antidepressive Agents | Monoamine Oxidase Inhibitors | Mood Stabilizers

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C1710661
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C3850058
UMLS CUI [3]
C3850053
UMLS CUI [4]
C3850041
UMLS CUI [5]
C0040615
UMLS CUI [6]
C0003289
UMLS CUI [7]
C0026457
UMLS CUI [8]
C4020582
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Similar models

Eligibility Schizophrenia NCT00706654

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 required by institutional review board/independent ethics committee [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 60 years of age, inclusive, at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Disease length
Item
subjects with a current diagnosis of schizophrenia as defined by diagnostic and statistical manual of mental disorders, version 4, text revision (dsm-iv-tr) criteria and a history of the illness for at least 3 years prior to screening.
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Patient need for Antipsychotic Agents chronic
Item
subjects who, in the investigator's judgment, require chronic treatment with an anti-psychotic 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 outcome 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 2 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 | Hypersensitivity Antipsychotic Agents
Item
subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents, including aripiprazole.
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])
C0020517 (UMLS CUI [7,1])
C0040615 (UMLS CUI [7,2])
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])
Abnormal thyroid function Uncontrolled
Item
subjects with uncontrolled thyroid function abnormalities.
boolean
C0857576 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Seizures | Neuroleptic Malignant Syndrome | Tardive Dyskinesia | Other medical condition At risk Patients | Other medical condition Interferes with Evaluation
Item
subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments.
boolean
C0036572 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
C0686347 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
Incarcerated Involuntary
Item
subjects who are involuntarily incarcerated.
boolean
C0392751 (UMLS CUI [1,1])
C2986385 (UMLS CUI [1,2])
Electroconvulsive Therapy
Item
subjects who have undergone electroconvulsive therapy within 180 days of entry into phase 2.
boolean
C0013806 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status | Aripiprazole Depot Preparation Intramuscular injection
Item
subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole im depot.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0299792 (UMLS CUI [3,1])
C0086129 (UMLS CUI [3,2])
C0021492 (UMLS CUI [3,3])
Laboratory test result abnormal | Abnormal vital signs | ECG abnormal
Item
subjects with clinically significant abnormalities in laboratory test results, vital signs, or ecg results.
boolean
C0438215 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Hospital stay duration
Item
subjects hospitalized for more than 30 days in the 90 days prior to phase 1 (or phase 2 for subjects bypassing phase 1).
boolean
C4019086 (UMLS CUI [1])
Benzodiazepines Quantity | Lorazepam | Oxazepam
Item
subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam).
boolean
C0005064 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024002 (UMLS CUI [2])
C0029997 (UMLS CUI [3])
Illicit Drugs Washout failed | CYP2D6 Inhibitors | CYP3A4 Inhibitors | CYP3A4 Inducers | Antipsychotic Agents | Antidepressive Agents | Monoamine Oxidase Inhibitors | Mood Stabilizers
Item
subjects who fail to wash-out from prohibited concomitant medications, including the use of cyp2d6 or cyp3a4 inhibitors or cyp3a4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [maoi]), and mood stabilizers, during screening and phase 1.
boolean
C0086190 (UMLS CUI [1,1])
C1710661 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C3850058 (UMLS CUI [2])
C3850053 (UMLS CUI [3])
C3850041 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
C0003289 (UMLS CUI [6])
C0026457 (UMLS CUI [7])
C4020582 (UMLS CUI [8])
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