ID

37179

Beschrijving

Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02040883

Link

https://clinicaltrials.gov/show/NCT02040883

Trefwoorden

Versies (1)
  1. 06-07-19 06-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02040883

Engels

Eligibility Schizophrenia NCT02040883

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnostic and statistical manual of mental disorders-iv edition (dsm-iv) diagnostic criteria for schizophrenia patients.
Beschrijving

Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
18-65 years (including 18 and 65), male or female.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
treated with a stable dose of an aapd for at least three months.
Beschrijving

Atypical antipsychotic Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent).
Beschrijving

Informed Consent | Informed Consent Guardian

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
panss negative score ≤60.
Beschrijving

PANSS Clinical Classification Item score Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0559741
UMLS CUI [1,3]
C1513916
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
combined axisⅰmental illness other than schizophrenia;
Beschrijving

Axis I diagnosis Combined | Exception Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205195
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function;
Beschrijving

Mood Stabilizer | Antidepressive Agents | Anticholinergic Agents | Anti-Anxiety Agents | Pharmaceutical Preparations Improve Cognitive function

Datatype

boolean

Alias
UMLS CUI [1]
C2917435
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0242896
UMLS CUI [4]
C0040616
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0184511
UMLS CUI [5,3]
C0392335
suicidal tendencies;
Beschrijving

Suicidal tendency

Datatype

boolean

Alias
UMLS CUI [1]
C0235196
have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients
Beschrijving

Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Endocrine System Disease Severe | Hematological Disease Severe | Other medical condition Severe | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Endocrine System Diseases Unstable | Hematological Disease Unstable | Other medical condition Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0014130
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0018939
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C0443343
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0022658
UMLS CUI [9,2]
C0443343
UMLS CUI [10,1]
C0014130
UMLS CUI [10,2]
C0443343
UMLS CUI [11,1]
C0018939
UMLS CUI [11,2]
C0443343
UMLS CUI [12,1]
C3843040
UMLS CUI [12,2]
C0443343
clinically significant ecg or laboratory abnormalities were
Beschrijving

Electrocardiography Clinical Significance | Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438215
glaucoma and epilepsy;
Beschrijving

Glaucoma | Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0017601
UMLS CUI [2]
C0014544
unsupervised or unable to take prescribed medication;
Beschrijving

Patient supervision Absent | Intake Prescribed medication Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0814286
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C2239117
UMLS CUI [2,3]
C1299582
history of alcohol and drug abuse;
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
allergic;
Beschrijving

allergic

Datatype

boolean

Alias
UMLS CUI [1]
C0700624
pregnant or lactating woman;
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients participate in other clinical trials during a month;
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Schizophrenia NCT02040883

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
diagnostic and statistical manual of mental disorders-iv edition (dsm-iv) diagnostic criteria for schizophrenia patients.
boolean
C0036341 (UMLS CUI [1])
Age
Item
18-65 years (including 18 and 65), male or female.
boolean
C0001779 (UMLS CUI [1])
Atypical antipsychotic Dose Stable
Item
treated with a stable dose of an aapd for at least three months.
boolean
C1276996 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Informed Consent | Informed Consent Guardian
Item
informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent).
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
PANSS Clinical Classification Item score Negative
Item
panss negative score ≤60.
boolean
C4086747 (UMLS CUI [1,1])
C0559741 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Combined | Exception Schizophrenia
Item
combined axisⅰmental illness other than schizophrenia;
boolean
C0270287 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Mood Stabilizer | Antidepressive Agents | Anticholinergic Agents | Anti-Anxiety Agents | Pharmaceutical Preparations Improve Cognitive function
Item
taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function;
boolean
C2917435 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
C0242896 (UMLS CUI [3])
C0040616 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0184511 (UMLS CUI [5,2])
C0392335 (UMLS CUI [5,3])
Suicidal tendency
Item
suicidal tendencies;
boolean
C0235196 (UMLS CUI [1])
Heart Disease Severe | Liver disease Severe | Kidney Disease Severe | Endocrine System Disease Severe | Hematological Disease Severe | Other medical condition Severe | Heart Disease Unstable | Liver disease Unstable | Kidney Disease Unstable | Endocrine System Diseases Unstable | Hematological Disease Unstable | Other medical condition Unstable
Item
have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0014130 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0018939 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0018799 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0022658 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C0014130 (UMLS CUI [10,1])
C0443343 (UMLS CUI [10,2])
C0018939 (UMLS CUI [11,1])
C0443343 (UMLS CUI [11,2])
C3843040 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
Electrocardiography Clinical Significance | Laboratory test result abnormal
Item
clinically significant ecg or laboratory abnormalities were
boolean
C1623258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Glaucoma | Epilepsy
Item
glaucoma and epilepsy;
boolean
C0017601 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Patient supervision Absent | Intake Prescribed medication Unable
Item
unsupervised or unable to take prescribed medication;
boolean
C0814286 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1512806 (UMLS CUI [2,1])
C2239117 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Substance Use Disorders
Item
history of alcohol and drug abuse;
boolean
C0038586 (UMLS CUI [1])
allergic
Item
allergic;
boolean
C0700624 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
patients participate in other clinical trials during a month;
boolean
C2348568 (UMLS CUI [1])
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