ID

37171

Descripción

A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone; ODM derived from: https://clinicaltrials.gov/show/NCT02019329

Link

https://clinicaltrials.gov/show/NCT02019329

Palabras clave

Versiones (1)
  1. 5/7/19 5/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02019329

Inglés

Eligibility Schizophrenia NCT02019329

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females aged >/= 18 years and </= 60 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
clinically stable, mild or moderate schizophrenia
Descripción

Stable status Clinical | Schizophrenia Mild | Schizophrenia Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0036341
UMLS CUI [3,2]
C0205081
on stable antipsychotic treatment for the last 6 months
Descripción

Antipsychotic drug therapy Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0205360
generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ecg), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
Descripción

General health good Medical History | General health good Physical Examination | General health good Vital signs | General health good Electrocardiography | General health good Hematology | General health good Clinical Chemistry Tests | General health good Urinalysis | General health good Serologic tests | General health good Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C0518766
UMLS CUI [4,1]
C1277245
UMLS CUI [4,2]
C1623258
UMLS CUI [5,1]
C1277245
UMLS CUI [5,2]
C0200627
UMLS CUI [6,1]
C1277245
UMLS CUI [6,2]
C0525044
UMLS CUI [7,1]
C1277245
UMLS CUI [7,2]
C0042014
UMLS CUI [8,1]
C1277245
UMLS CUI [8,2]
C0036743
UMLS CUI [9,1]
C1277245
UMLS CUI [9,2]
C0022885
willingness to be hospitalized for approximately 3 weeks
Descripción

Hospitalization Duration Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0600109
bmi > 18.5 kg/m2 and < 38 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
use of highly effective contraception as defined by the study protocol. men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding
Descripción

Contraceptive methods | Gender Sperm donation Absent | Gender Pregnancy Absent | Gender Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0871414
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0032961
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0006147
UMLS CUI [4,3]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with antiparkinson medication including anticholinergic drugs
Descripción

Antiparkinson Agents | Anticholinergic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003405
UMLS CUI [2]
C0242896
treatment with depot antipsychotic medication within the last three months prior to screening
Descripción

Injection of depot antipsychotic agent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2585377
participation in a clinical trial with an investigational drug or device < 3 months prior to screening
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
smokes more than 20 cigarettes per day
Descripción

Tobacco use Number of cigarettes per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
Descripción

Drug abuse | Exception Nicotine abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2363943
any donation of blood or significant blood loss within three months prior to first administration of the study drug
Descripción

Blood Donation | Blood Loss Significant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C0750502
use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration
Descripción

Illicit medication use | Vitamins Illicit | Herbal medicine (product) Illicit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2,1]
C0042890
UMLS CUI [2,2]
C0332266
UMLS CUI [3,1]
C2240391
UMLS CUI [3,2]
C0332266
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Similar models

Eligibility Schizophrenia NCT02019329

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females aged >/= 18 years and </= 60 years
boolean
C0001779 (UMLS CUI [1])
Stable status Clinical | Schizophrenia Mild | Schizophrenia Moderate
Item
clinically stable, mild or moderate schizophrenia
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Antipsychotic drug therapy Stable
Item
on stable antipsychotic treatment for the last 6 months
boolean
C1319421 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
General health good Medical History | General health good Physical Examination | General health good Vital signs | General health good Electrocardiography | General health good Hematology | General health good Clinical Chemistry Tests | General health good Urinalysis | General health good Serologic tests | General health good Laboratory Procedures
Item
generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ecg), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C1623258 (UMLS CUI [4,2])
C1277245 (UMLS CUI [5,1])
C0200627 (UMLS CUI [5,2])
C1277245 (UMLS CUI [6,1])
C0525044 (UMLS CUI [6,2])
C1277245 (UMLS CUI [7,1])
C0042014 (UMLS CUI [7,2])
C1277245 (UMLS CUI [8,1])
C0036743 (UMLS CUI [8,2])
C1277245 (UMLS CUI [9,1])
C0022885 (UMLS CUI [9,2])
Hospitalization Duration Willing
Item
willingness to be hospitalized for approximately 3 weeks
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Body mass index
Item
bmi > 18.5 kg/m2 and < 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods | Gender Sperm donation Absent | Gender Pregnancy Absent | Gender Breast Feeding Absent
Item
use of highly effective contraception as defined by the study protocol. men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding
boolean
C0700589 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0871414 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0006147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Antiparkinson Agents | Anticholinergic Agents
Item
treatment with antiparkinson medication including anticholinergic drugs
boolean
C0003405 (UMLS CUI [1])
C0242896 (UMLS CUI [2])
Injection of depot antipsychotic agent
Item
treatment with depot antipsychotic medication within the last three months prior to screening
boolean
C2585377 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in a clinical trial with an investigational drug or device < 3 months prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Tobacco use Number of cigarettes per day
Item
smokes more than 20 cigarettes per day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Drug abuse | Exception Nicotine abuse
Item
current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
boolean
C0013146 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2363943 (UMLS CUI [2,2])
Blood Donation | Blood Loss Significant
Item
any donation of blood or significant blood loss within three months prior to first administration of the study drug
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Illicit medication use | Vitamins Illicit | Herbal medicine (product) Illicit
Item
use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration
boolean
C0281875 (UMLS CUI [1])
C0042890 (UMLS CUI [2,1])
C0332266 (UMLS CUI [2,2])
C2240391 (UMLS CUI [3,1])
C0332266 (UMLS CUI [3,2])
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