ID

32160

Beskrivning

A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00888693

Länk

https://clinicaltrials.gov/show/NCT00888693

Nyckelord

Versioner (1)
  1. 2018-10-22 2018-10-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00888693

Engelsk

Eligibility Schizophrenia NCT00888693

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has signed informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
current dsm-iv-tr diagnosis of schizophrenia;
Beskrivning

Schizophrenia

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
Beskrivning

Antipsychotic Agent Generation second | Antipsychotic Agent Same Single Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0445247
UMLS CUI [2,3]
C0205171
UMLS CUI [2,4]
C0205360
meets study-specific panss criteria;
Beskrivning

PANSS Study Protocol Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C1550543
willing and able to cooperate with cognitive testing
Beskrivning

Cooperative Behavior Testing Cognitive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009964
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1516691
females are not pregnant, not breast-feeding;
Beskrivning

Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
females are post-menopausal or surgically sterile or practicing birth control;
Beskrivning

Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
Beskrivning

Male sterilization | Gender Sexual Abstinence | Gender Barrier Contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0024559
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0004764
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
Beskrivning

Substance Dependence | Remission Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0332268
diagnosis of schizoaffective disorder;
Beskrivning

Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036337
bipolar disorder, manic episode, dementia, ocd, or drug-induced psychosis or current major depressive disorder;
Beskrivning

Bipolar Disorder | Manic episode | Dementia | Obsessive-Compulsive Disorder | Drug induced psychosis | Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0349208
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0033937
UMLS CUI [6]
C1269683
diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
Beskrivning

Mental Retardation | Hospitalization Due to Psychotic Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0033975
current clozapine treatment; suicidal ideation or behavior;
Beskrivning

Clozapine | Feeling suicidal | Suicidal behavior

Datatyp

boolean

Alias
UMLS CUI [1]
C0009079
UMLS CUI [2]
C0424000
UMLS CUI [3]
C1760428
bmi of 39 or greater; current homicidal or violent ideation;
Beskrivning

Body mass index | Homicidal thoughts | Violent ideation

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0455204
UMLS CUI [3]
C1868823
medical or cns condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
Beskrivning

Medical condition Affecting Cognition | CNS disorder Affecting Cognition | Medical condition Affecting Testing Cognitive | CNS disorder Affecting Testing Cognitive | Exception Schizophrenia | Drug Allergy | Urine screen Positive Substance of abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0009240
UMLS CUI [2,1]
C0007682
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0009240
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0039593
UMLS CUI [3,4]
C1516691
UMLS CUI [4,1]
C0007682
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0039593
UMLS CUI [4,4]
C1516691
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0036341
UMLS CUI [6]
C0013182
UMLS CUI [7,1]
C0595946
UMLS CUI [7,2]
C1514241
UMLS CUI [7,3]
C0687130
positive hepatitis or hiv test result;
Beskrivning

Hepatitis viral test positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C3495836
UMLS CUI [2]
C0019699
recent clinically significant illness/infection or surgery;
Beskrivning

Illness Clinical Significance | Communicable Disease | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0543467
recent blood product transfusion, donation or loss of 5 ml/kg of blood;
Beskrivning

Blood Transfusion | Blood Donation Amount | Blood Loss Amount

Datatyp

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C1265611
visual, hearing or communication disability
Beskrivning

Vision Disability | Hearing disability | Communication Disability

Datatyp

boolean

Alias
UMLS CUI [1]
C3489704
UMLS CUI [2]
C0848765
UMLS CUI [3]
C0751049
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Similar models

Eligibility Schizophrenia NCT00888693

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject has signed informed consent;
boolean
C0021430 (UMLS CUI [1])
Schizophrenia
Item
current dsm-iv-tr diagnosis of schizophrenia;
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agent Generation second | Antipsychotic Agent Same Single Stable
Item
clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
boolean
C0040615 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
PANSS Study Protocol Criteria Fulfill
Item
meets study-specific panss criteria;
boolean
C4086747 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1550543 (UMLS CUI [1,4])
Cooperative Behavior Testing Cognitive
Item
willing and able to cooperate with cognitive testing
boolean
C0009964 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1516691 (UMLS CUI [1,3])
Pregnancy Absent | Breast Feeding Absent
Item
females are not pregnant, not breast-feeding;
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
females are post-menopausal or surgically sterile or practicing birth control;
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Male sterilization | Gender Sexual Abstinence | Gender Barrier Contraception
Item
males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
boolean
C0024559 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Substance Dependence | Remission Lacking
Item
subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
boolean
C0038580 (UMLS CUI [1])
C0544452 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Schizoaffective Disorder
Item
diagnosis of schizoaffective disorder;
boolean
C0036337 (UMLS CUI [1])
Bipolar Disorder | Manic episode | Dementia | Obsessive-Compulsive Disorder | Drug induced psychosis | Major Depressive Disorder
Item
bipolar disorder, manic episode, dementia, ocd, or drug-induced psychosis or current major depressive disorder;
boolean
C0005586 (UMLS CUI [1])
C0349208 (UMLS CUI [2])
C0497327 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0033937 (UMLS CUI [5])
C1269683 (UMLS CUI [6])
Mental Retardation | Hospitalization Due to Psychotic Disorder
Item
diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
boolean
C0025362 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0033975 (UMLS CUI [2,3])
Clozapine | Feeling suicidal | Suicidal behavior
Item
current clozapine treatment; suicidal ideation or behavior;
boolean
C0009079 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
C1760428 (UMLS CUI [3])
Body mass index | Homicidal thoughts | Violent ideation
Item
bmi of 39 or greater; current homicidal or violent ideation;
boolean
C1305855 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
C1868823 (UMLS CUI [3])
Medical condition Affecting Cognition | CNS disorder Affecting Cognition | Medical condition Affecting Testing Cognitive | CNS disorder Affecting Testing Cognitive | Exception Schizophrenia | Drug Allergy | Urine screen Positive Substance of abuse
Item
medical or cns condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0009240 (UMLS CUI [1,3])
C0007682 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0009240 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0039593 (UMLS CUI [3,3])
C1516691 (UMLS CUI [3,4])
C0007682 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0039593 (UMLS CUI [4,3])
C1516691 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0036341 (UMLS CUI [5,2])
C0013182 (UMLS CUI [6])
C0595946 (UMLS CUI [7,1])
C1514241 (UMLS CUI [7,2])
C0687130 (UMLS CUI [7,3])
Hepatitis viral test positive | HIV Seropositivity
Item
positive hepatitis or hiv test result;
boolean
C3495836 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Illness Clinical Significance | Communicable Disease | Operative Surgical Procedures
Item
recent clinically significant illness/infection or surgery;
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Blood Transfusion | Blood Donation Amount | Blood Loss Amount
Item
recent blood product transfusion, donation or loss of 5 ml/kg of blood;
boolean
C0005841 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Vision Disability | Hearing disability | Communication Disability
Item
visual, hearing or communication disability
boolean
C3489704 (UMLS CUI [1])
C0848765 (UMLS CUI [2])
C0751049 (UMLS CUI [3])
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