ID

30545

Description

Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT00955474

Link

https://clinicaltrials.gov/show/NCT00955474

Keywords

Versions (1)
  1. 6/13/18 6/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder With Psychotic Features NCT00955474

English

Eligibility Major Depressive Disorder With Psychotic Features NCT00955474

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosis of major depressive disorder with psychotic features by the dsm-iv
Description

DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE

Data type

boolean

Alias
UMLS CUI [1]
C0743080
3. females and males between the ages of 18-85 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrolment
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative HCG

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [2,3]
C1141639
5. able to understand and comply with the requirements of the study
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
6. initial ham-d-17 score of > 16, both at the screen visit and at the baseline visit.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0205265
7. participants must have an initial bprs score of > 25 and at least one of the following: > 5 for item 1, > 5 for item 5, > 5 for item 8, > 4 for item 9, > 1 for item 10, > 1 for item 11; these bprs criteria msut be met both at the screen visit and at the baseline visit.
Description

Brief Psychiatric Rating Scale Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C0029941
UMLS CUI [1,2]
C0205265
8. participants must have an initial cgi score of > 2, both at the screen visit and at the baseline visit.
Description

Clinical global impression scale Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C0205265
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. any dsm-iv axis i disorder not defined in the inclusion criteria
Description

Axis I diagnosis | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
3. patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Description

At risk for suicide | DANGER OF HARM TO SELF | Risk of violence or harm to others

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C0149660
UMLS CUI [3]
C0549013
4. known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
Description

Intolerance to Quetiapine fumarate | Response Lacking Quetiapine fumarate

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0724680
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0724680
5. use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Description

Cytochrome P-450 CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Fluconazole | Erythromycin | Clarithromycin | Troleandomycin | Indinavir | Nelfinavir | Ritonavir | Fluvoxamine | Saquinavir

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0064113
UMLS CUI [4]
C0016277
UMLS CUI [5]
C0014806
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0041165
UMLS CUI [8]
C0376637
UMLS CUI [9]
C0525005
UMLS CUI [10]
C0292818
UMLS CUI [11]
C0085228
UMLS CUI [12]
C0286738
6. use of any of the following cytochrome p450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids
Description

Cytochrome P450 3A4 Inducer | Phenytoin | Carbamazepine | Barbiturates | Rifampin | Hypericum perforatum | Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C3830625
UMLS CUI [2]
C0031507
UMLS CUI [3]
C0006949
UMLS CUI [4]
C0004745
UMLS CUI [5]
C0035608
UMLS CUI [6]
C0936242
UMLS CUI [7]
C0017710
7. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
8. substance or alcohol dependence within the past three months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria
Description

Substance Dependence | Exception Dependence Remission | Exception Caffeine dependence | Exception Nicotine Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038580
UMLS CUI [2,3]
C0544452
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1386553
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0028043
9. opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrolment
Description

Opioid abuse | Amphetamine Abuse | Barbiturate abuse | Cocaine Abuse | Cannabis Abuse | Hallucinogen abuse

Data type

boolean

Alias
UMLS CUI [1]
C0029095
UMLS CUI [2]
C0236807
UMLS CUI [3]
C0338700
UMLS CUI [4]
C0009171
UMLS CUI [5]
C0006868
UMLS CUI [6]
C0018526
10. medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Description

Medical condition Affecting Absorption Investigational New Drugs | Medical condition Affecting Distribution Investigational New Drugs | Medical condition Affecting Metabolism Investigational New Drugs | Medical condition Affecting Excretion Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1378698
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0025520
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0683141
UMLS CUI [4,4]
C0013230
11. unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
Description

Illness Unstable | Illness Treated Inadequate | Diabetes Mellitus | Angina Pectoris | Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205412
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0020538
12. involvement in the planning and conduct of the study
Description

Involvement Clinical Trial Planning | Involvement Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C2732579
13. previous enrolment or randomization of treatment in the present study.
Description

Study Subject Participation Status | Randomization Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0087111
14. participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
15. a patient with diabetes mellitus (dm) fulfilling one of the following criteria:
Description

Diabetes Mellitus | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
unstable dm defined as enrollment glycosylated hemoglobin (hba1c) > 8.5%.
Description

Diabetes Mellitus Unstable | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0474680
admitted to hospital for treatment of dm or dm related illness in past 12 weeks.
Description

Hospital admission | Therapeutic procedure Diabetes Mellitus | Therapeutic procedure Illness Relationship Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0184666
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0011849
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0221423
UMLS CUI [3,3]
C0439849
UMLS CUI [3,4]
C0011849
not under physician care for dm.
Description

Under care of doctor Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0583348
UMLS CUI [1,2]
C0011849
physician responsible for patient's dm care has not indicated that patient's dm is controlled.
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
physician responsible for patient's dm care has not approved patient's participation in the study
Description

Study Subject Participation Status Approval Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0332268
has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. for thiazolidinediones (glitazones) this period should not be less than 8 weeks.
Description

Oral hypoglycemic Dose Changed | Diet Dose Changed | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3]
C1257987
taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
Description

Insulin Dose Abnormal Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205161
UMLS CUI [1,4]
C1265611
16. an absolute neutrophil count (anc) of 1.5 x 10^9 per liter
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
17. patients with a history seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
Description

Epilepsy | Physical illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease | Physical illness Affecting Central nervous system function

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0035204
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0018939
UMLS CUI [10,1]
C0683323
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0683212
18. patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine.
Description

Antidepressive Agents | Exception Selective Serotonin Reuptake Inhibitors | Mood Stabilizer | Antipsychotic Agents | Exception Quetiapine

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0360105
UMLS CUI [3]
C2917435
UMLS CUI [4]
C0040615
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0123091
19. patients with known arrhythmias or arrhythmias noted on screening ekg.
Description

Cardiac Arrhythmia | Cardiac Arrhythmia Screening ECG

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0013798
20. outpatients with a cgi score of 7.
Description

Outpatients | Clinical global impression scale

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C3639708
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Similar models

Eligibility Major Depressive Disorder With Psychotic Features NCT00955474

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE
Item
2. diagnosis of major depressive disorder with psychotic features by the dsm-iv
boolean
C0743080 (UMLS CUI [1])
Age
Item
3. females and males between the ages of 18-85 years.
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative HCG
Item
4. female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrolment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C1141639 (UMLS CUI [2,3])
Protocol Compliance
Item
5. able to understand and comply with the requirements of the study
boolean
C0525058 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification Initial
Item
6. initial ham-d-17 score of > 16, both at the screen visit and at the baseline visit.
boolean
C3639712 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Brief Psychiatric Rating Scale Initial
Item
7. participants must have an initial bprs score of > 25 and at least one of the following: > 5 for item 1, > 5 for item 5, > 5 for item 8, > 4 for item 9, > 1 for item 10, > 1 for item 11; these bprs criteria msut be met both at the screen visit and at the baseline visit.
boolean
C0029941 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Clinical global impression scale Initial
Item
8. participants must have an initial cgi score of > 2, both at the screen visit and at the baseline visit.
boolean
C3639708 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Axis I diagnosis | Exception Inclusion criteria
Item
2. any dsm-iv axis i disorder not defined in the inclusion criteria
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
At risk for suicide | DANGER OF HARM TO SELF | Risk of violence or harm to others
Item
3. patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
boolean
C0563664 (UMLS CUI [1])
C0149660 (UMLS CUI [2])
C0549013 (UMLS CUI [3])
Intolerance to Quetiapine fumarate | Response Lacking Quetiapine fumarate
Item
4. known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
boolean
C1744706 (UMLS CUI [1,1])
C0724680 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0724680 (UMLS CUI [2,3])
Cytochrome P-450 CYP3A4 Inhibitors | Ketoconazole | Itraconazole | Fluconazole | Erythromycin | Clarithromycin | Troleandomycin | Indinavir | Nelfinavir | Ritonavir | Fluvoxamine | Saquinavir
Item
5. use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
boolean
C3850053 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0064113 (UMLS CUI [3])
C0016277 (UMLS CUI [4])
C0014806 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0041165 (UMLS CUI [7])
C0376637 (UMLS CUI [8])
C0525005 (UMLS CUI [9])
C0292818 (UMLS CUI [10])
C0085228 (UMLS CUI [11])
C0286738 (UMLS CUI [12])
Cytochrome P450 3A4 Inducer | Phenytoin | Carbamazepine | Barbiturates | Rifampin | Hypericum perforatum | Glucocorticoids
Item
6. use of any of the following cytochrome p450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids
boolean
C3830625 (UMLS CUI [1])
C0031507 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
C0004745 (UMLS CUI [4])
C0035608 (UMLS CUI [5])
C0936242 (UMLS CUI [6])
C0017710 (UMLS CUI [7])
Injection of depot antipsychotic agent
Item
7. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization
boolean
C2585377 (UMLS CUI [1])
Substance Dependence | Exception Dependence Remission | Exception Caffeine dependence | Exception Nicotine Dependence
Item
8. substance or alcohol dependence within the past three months (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0038580 (UMLS CUI [2,2])
C0544452 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1386553 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0028043 (UMLS CUI [4,2])
Opioid abuse | Amphetamine Abuse | Barbiturate abuse | Cocaine Abuse | Cannabis Abuse | Hallucinogen abuse
Item
9. opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrolment
boolean
C0029095 (UMLS CUI [1])
C0236807 (UMLS CUI [2])
C0338700 (UMLS CUI [3])
C0009171 (UMLS CUI [4])
C0006868 (UMLS CUI [5])
C0018526 (UMLS CUI [6])
Medical condition Affecting Absorption Investigational New Drugs | Medical condition Affecting Distribution Investigational New Drugs | Medical condition Affecting Metabolism Investigational New Drugs | Medical condition Affecting Excretion Investigational New Drugs
Item
10. medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0025520 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Illness Unstable | Illness Treated Inadequate | Diabetes Mellitus | Angina Pectoris | Hypertensive disease
Item
11. unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
Involvement Clinical Trial Planning | Involvement Completion of clinical trial
Item
12. involvement in the planning and conduct of the study
boolean
C1314939 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])
Study Subject Participation Status | Randomization Therapeutic procedure
Item
13. previous enrolment or randomization of treatment in the present study.
boolean
C2348568 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Study Subject Participation Status
Item
14. participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements
boolean
C2348568 (UMLS CUI [1])
Diabetes Mellitus | Criteria Fulfill
Item
15. a patient with diabetes mellitus (dm) fulfilling one of the following criteria:
boolean
C0011849 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Diabetes Mellitus Unstable | Hemoglobin A1c measurement
Item
unstable dm defined as enrollment glycosylated hemoglobin (hba1c) > 8.5%.
boolean
C0011849 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Hospital admission | Therapeutic procedure Diabetes Mellitus | Therapeutic procedure Illness Relationship Diabetes Mellitus
Item
admitted to hospital for treatment of dm or dm related illness in past 12 weeks.
boolean
C0184666 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0221423 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0011849 (UMLS CUI [3,4])
Under care of doctor Diabetes Mellitus
Item
not under physician care for dm.
boolean
C0583348 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Diabetic - poor control
Item
physician responsible for patient's dm care has not indicated that patient's dm is controlled.
boolean
C0421258 (UMLS CUI [1])
Study Subject Participation Status Approval Lacking
Item
physician responsible for patient's dm care has not approved patient's participation in the study
boolean
C2348568 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Oral hypoglycemic Dose Changed | Diet Dose Changed | Thiazolidinediones
Item
has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. for thiazolidinediones (glitazones) this period should not be less than 8 weeks.
boolean
C0359086 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C1257987 (UMLS CUI [3])
Insulin Dose Abnormal Quantity
Item
taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Absolute neutrophil count
Item
16. an absolute neutrophil count (anc) of 1.5 x 10^9 per liter
boolean
C0948762 (UMLS CUI [1])
Epilepsy | Physical illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease | Physical illness Affecting Central nervous system function
Item
17. patients with a history seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
boolean
C0014544 (UMLS CUI [1])
C0683323 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0035204 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0683323 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0683212 (UMLS CUI [10,3])
Antidepressive Agents | Exception Selective Serotonin Reuptake Inhibitors | Mood Stabilizer | Antipsychotic Agents | Exception Quetiapine
Item
18. patients who are currently treated with antidepressants other than the selective serotonin reuptake inhibitors, with mood stabilizing or antipsychotic drugs other than quetiapine.
boolean
C0003289 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0360105 (UMLS CUI [2,2])
C2917435 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0123091 (UMLS CUI [5,2])
Cardiac Arrhythmia | Cardiac Arrhythmia Screening ECG
Item
19. patients with known arrhythmias or arrhythmias noted on screening ekg.
boolean
C0003811 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0013798 (UMLS CUI [2,3])
Outpatients | Clinical global impression scale
Item
20. outpatients with a cgi score of 7.
boolean
C0029921 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
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