ID

19355

Beskrivning

Efficacy of Pimozide Augmentation for Clozapine Partial Response; ODM derived from: https://clinicaltrials.gov/show/NCT00374244

Länk

https://clinicaltrials.gov/show/NCT00374244

Nyckelord

Versioner (1)
  1. 2016-12-20 2016-12-20 -
Uppladdad den

20 december 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00374244

Engelsk

Eligibility Schizophrenia NCT00374244

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of schizophrenia or schizoaffective disorder.
Beskrivning

Schizophrenia | Schizoaffective Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
a minimum brief psychiatric rating scale (bprs) score of 35 and a bprs psychotic symptom cluster score of at least 8.
Beskrivning

Brief Psychiatric Rating Scale | BPRS Psychotic symptom Cluster

Datatyp

boolean

Alias
UMLS CUI [1]
C0029941
UMLS CUI [2,1]
C0029941
UMLS CUI [2,2]
C0871189
UMLS CUI [2,3]
C1704332
currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
Beskrivning

Clozapine Dose Stable | Clozapine In Blood Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009079
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0009079
UMLS CUI [2,2]
C0005768
UMLS CUI [2,3]
C0242485
able to give informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
Beskrivning

Disease Significant | nervous system disorder Significant | Thyroid Disease | Renal abnormalities | Abnormality of the liver | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0750502
UMLS CUI [3]
C0040128
UMLS CUI [4]
C4014891
UMLS CUI [5]
C4021780
UMLS CUI [6]
C0014544
history of neuroleptic malignant syndrome.
Beskrivning

Neuroleptic Malignant Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0027849
current substance abuse determined by urine toxicology.
Beskrivning

Substance Use Disorders Urine Toxicology

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0852616
cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, wolff-parkinson-white syndrome, first, second, third degree atrioventricular (av) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (ekg). study doctors will examine the ekgs and consult with an internist/cardiologist as needed.
Beskrivning

Cardiac Arrhythmia | Sinus bradycardia | heart rate | Sinus Tachycardia | Supraventricular tachycardia | Tachycardia, Ventricular | Wolff-Parkinson-White Syndrome | First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter | Junctional premature complex | Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0085610
UMLS CUI [3]
C0018810
UMLS CUI [4]
C0039239
UMLS CUI [5]
C0039240
UMLS CUI [6]
C0042514
UMLS CUI [7]
C0043202
UMLS CUI [8]
C0085614
UMLS CUI [9]
C0264906
UMLS CUI [10]
C0151517
UMLS CUI [11]
C0004238
UMLS CUI [12]
C0004239
UMLS CUI [13]
C0428981
UMLS CUI [14]
C1623258
on ekg: qtc > 450 ms.
Beskrivning

ECG QTc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C2216079
current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged qtc.
Beskrivning

Macrolide Antibiotics | Erythromycin | Clarithromycin | Azole antifungal | Ketoconazole | Itraconazole | Protease Inhibitors | Ritonavir | Indinavir | nefazodone | Pharmaceutical Preparations Associated with Prolonged QTc

Datatyp

boolean

Alias
UMLS CUI [1]
C0003240
UMLS CUI [2]
C0014806
UMLS CUI [3]
C0055856
UMLS CUI [4]
C0360363
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0064113
UMLS CUI [7]
C0033607
UMLS CUI [8]
C0292818
UMLS CUI [9]
C0376637
UMLS CUI [10]
C0068485
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C0332281
UMLS CUI [11,3]
C1969409
current use of antipsychotics other than clozapine.
Beskrivning

Antipsychotic Agents | Clozapine

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0009079
current use of sertraline.
Beskrivning

Sertraline

Datatyp

boolean

Alias
UMLS CUI [1]
C0074393
iq level below 70.
Beskrivning

Intelligence quotient

Datatyp

boolean

Alias
UMLS CUI [1]
C0456149
at high risk for suicidal/homicidal behavior.
Beskrivning

Suicidal behavior High risk of | Homicidal behavior High risk of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1760428
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C1828354
UMLS CUI [2,2]
C0332167
pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Lack | Gender Contraceptive methods | Contraceptives, Oral | Female Condoms | Contraception, Barrier | Sexual Abstinence | Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
UMLS CUI [8]
C0015787
non-english speaking.
Beskrivning

Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
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Similar models

Eligibility Schizophrenia NCT00374244

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Schizoaffective Disorder
Item
diagnosis of schizophrenia or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Brief Psychiatric Rating Scale | BPRS Psychotic symptom Cluster
Item
a minimum brief psychiatric rating scale (bprs) score of 35 and a bprs psychotic symptom cluster score of at least 8.
boolean
C0029941 (UMLS CUI [1])
C0029941 (UMLS CUI [2,1])
C0871189 (UMLS CUI [2,2])
C1704332 (UMLS CUI [2,3])
Clozapine Dose Stable | Clozapine In Blood Measurement
Item
currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
boolean
C0009079 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0009079 (UMLS CUI [2,1])
C0005768 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Informed Consent
Item
able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Significant | nervous system disorder Significant | Thyroid Disease | Renal abnormalities | Abnormality of the liver | Epilepsy
Item
a history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0040128 (UMLS CUI [3])
C4014891 (UMLS CUI [4])
C4021780 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
Neuroleptic Malignant Syndrome
Item
history of neuroleptic malignant syndrome.
boolean
C0027849 (UMLS CUI [1])
Substance Use Disorders Urine Toxicology
Item
current substance abuse determined by urine toxicology.
boolean
C0038586 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0852616 (UMLS CUI [1,3])
Cardiac Arrhythmia | Sinus bradycardia | heart rate | Sinus Tachycardia | Supraventricular tachycardia | Tachycardia, Ventricular | Wolff-Parkinson-White Syndrome | First degree atrioventricular block | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Atrial Flutter | Junctional premature complex | Electrocardiography
Item
cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, wolff-parkinson-white syndrome, first, second, third degree atrioventricular (av) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (ekg). study doctors will examine the ekgs and consult with an internist/cardiologist as needed.
boolean
C0003811 (UMLS CUI [1])
C0085610 (UMLS CUI [2])
C0018810 (UMLS CUI [3])
C0039239 (UMLS CUI [4])
C0039240 (UMLS CUI [5])
C0042514 (UMLS CUI [6])
C0043202 (UMLS CUI [7])
C0085614 (UMLS CUI [8])
C0264906 (UMLS CUI [9])
C0151517 (UMLS CUI [10])
C0004238 (UMLS CUI [11])
C0004239 (UMLS CUI [12])
C0428981 (UMLS CUI [13])
C1623258 (UMLS CUI [14])
ECG QTc interval
Item
on ekg: qtc > 450 ms.
boolean
C2216079 (UMLS CUI [1])
Macrolide Antibiotics | Erythromycin | Clarithromycin | Azole antifungal | Ketoconazole | Itraconazole | Protease Inhibitors | Ritonavir | Indinavir | nefazodone | Pharmaceutical Preparations Associated with Prolonged QTc
Item
current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged qtc.
boolean
C0003240 (UMLS CUI [1])
C0014806 (UMLS CUI [2])
C0055856 (UMLS CUI [3])
C0360363 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0033607 (UMLS CUI [7])
C0292818 (UMLS CUI [8])
C0376637 (UMLS CUI [9])
C0068485 (UMLS CUI [10])
C0013227 (UMLS CUI [11,1])
C0332281 (UMLS CUI [11,2])
C1969409 (UMLS CUI [11,3])
Antipsychotic Agents | Clozapine
Item
current use of antipsychotics other than clozapine.
boolean
C0040615 (UMLS CUI [1])
C0009079 (UMLS CUI [2])
Sertraline
Item
current use of sertraline.
boolean
C0074393 (UMLS CUI [1])
Intelligence quotient
Item
iq level below 70.
boolean
C0456149 (UMLS CUI [1])
Suicidal behavior High risk of | Homicidal behavior High risk of
Item
at high risk for suicidal/homicidal behavior.
boolean
C1760428 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1828354 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Contraceptive methods Lack | Gender Contraceptive methods | Contraceptives, Oral | Female Condoms | Contraception, Barrier | Sexual Abstinence | Female Sterilization
Item
pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
Able to speak English Language
Item
non-english speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
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