ID

32220

Beschreibung

Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01043458

Link

https://clinicaltrials.gov/show/NCT01043458

Stichworte

Versionen (1)
  1. 23.10.18 23.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT01043458

Englisch

Eligibility Schizophrenia NCT01043458

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has signed informed consent;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
current diagnosis of schizophrenia;
Beschreibung

Schizophrenia

Datentyp

boolean

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

Atypical antipsychotic Generation second | Atypical antipsychotic Same Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [2,1]
C1276996
UMLS CUI [2,2]
C0445247
UMLS CUI [2,3]
C0205360
meets study-specific criteria for positive and negative syndrome scale (panss);
Beschreibung

PANSS Study Protocol Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0243161
females are not pregnant, not breast-feeding;
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
females are post-menopausal or surgically sterile or practicing birth control;
Beschreibung

Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datentyp

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
Beschreibung

Male sterilization | Gender Sexual Abstinence | Gender Barrier Contraception

Datentyp

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
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of schizoaffective disorder;
Beschreibung

Schizoaffective Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0036337
diagnosis with mental retardation;
Beschreibung

Mental Retardation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025362
subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
Beschreibung

Substance Dependence | Remission Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0332268
acute psychosis hospitalization within past 6 months;
Beschreibung

Hospitalization Acute psychosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0281774
bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
Beschreibung

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

Datentyp

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
current clozapine treatment;
Beschreibung

Clozapine

Datentyp

boolean

Alias
UMLS CUI [1]
C0009079
suicidal ideation or behavior;
Beschreibung

Feeling suicidal | Suicidal behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C1760428
bmi of 39 or greater;
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
relevant drug sensitivity or allergy;
Beschreibung

Drug Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
positive hepatitis or hiv test result; positive urine screen for drugs of abuse or alcohol;
Beschreibung

Hepatitis viral test positive | HIV Seropositivity | Urine drug abuse screen Positive | Urine screen Alcohol use Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C3495836
UMLS CUI [2]
C0019699
UMLS CUI [3,1]
C1278212
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0595946
UMLS CUI [4,2]
C0001948
UMLS CUI [4,3]
C1514241
recent clinically significant illness/infection or surgery;
Beschreibung

Illness Clinical Significance | Communicable Disease | Operative Surgical Procedures

Datentyp

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;
Beschreibung

Blood Product Transfusion | Blood Donation Amount | Blood Loss Amount

Datentyp

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
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Ähnliche Modelle

Eligibility Schizophrenia NCT01043458

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject has signed informed consent;
boolean
C0021430 (UMLS CUI [1])
Schizophrenia
Item
current diagnosis of schizophrenia;
boolean
C0036341 (UMLS CUI [1])
Atypical antipsychotic Generation second | Atypical antipsychotic Same Stable
Item
clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
boolean
C1276996 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C1276996 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
PANSS Study Protocol Criteria
Item
meets study-specific criteria for positive and negative syndrome scale (panss);
boolean
C4086747 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Gender | Pregnancy Absent | Breast Feeding Absent
Item
females are not pregnant, not breast-feeding;
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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)
Schizoaffective Disorder
Item
diagnosis of schizoaffective disorder;
boolean
C0036337 (UMLS CUI [1])
Mental Retardation
Item
diagnosis with mental retardation;
boolean
C0025362 (UMLS CUI [1])
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])
Hospitalization Acute psychosis
Item
acute psychosis hospitalization within past 6 months;
boolean
C0019993 (UMLS CUI [1,1])
C0281774 (UMLS CUI [1,2])
Bipolar Disorder | Manic episode | Dementia | Obsessive-Compulsive Disorder | Drug-induced psychosis | Major Depressive Disorder
Item
bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, 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])
Clozapine
Item
current clozapine treatment;
boolean
C0009079 (UMLS CUI [1])
Feeling suicidal | Suicidal behavior
Item
suicidal ideation or behavior;
boolean
C0424000 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
Body mass index
Item
bmi of 39 or greater;
boolean
C1305855 (UMLS CUI [1])
Drug Allergy
Item
relevant drug sensitivity or allergy;
boolean
C0013182 (UMLS CUI [1])
Hepatitis viral test positive | HIV Seropositivity | Urine drug abuse screen Positive | Urine screen Alcohol use Positive
Item
positive hepatitis or hiv test result; positive urine screen for drugs of abuse or alcohol;
boolean
C3495836 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C1278212 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0595946 (UMLS CUI [4,1])
C0001948 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
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 Product 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])
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