ID

24043

Beschreibung

The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00517387

Link

https://clinicaltrials.gov/show/NCT00517387

Stichworte

Versionen (1)
  1. 23.07.17 23.07.17 -
Hochgeladen am

23. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Unipolar Depression NCT00517387

Englisch

Eligibility Unipolar Depression NCT00517387

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent
Beschreibung

ID.1

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. a diagnosis of unipolar depression by diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv-tr)
Beschreibung

ID.2

Datentyp

boolean

Alias
UMLS CUI [1]
C0041696
3. females and males aged 19-65 years
Beschreibung

ID.3

Datentyp

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
Beschreibung

ID.4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009862
UMLS CUI [1,2]
C0032961
5. able to understand and comply with the requirements of the study
Beschreibung

ID.5

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
6. minimum 21-item ham-d grid score of 15
Beschreibung

ID.6

Datentyp

boolean

Alias
UMLS CUI [1]
C4273889
7. prior treatment with therapeutic doses of an ssri-type antidepressant for at least 6 weeks
Beschreibung

ID.7

Datentyp

boolean

Alias
UMLS CUI [1]
C0360105
8. unsatisfactory response to treatment, as determined by clinician, for at least 6 weeks.
Beschreibung

ID.8

Datentyp

boolean

Alias
UMLS CUI [1]
C0521982
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or lactation
Beschreibung

ID.9

Datentyp

boolean

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

ID.10

Datentyp

boolean

Alias
UMLS CUI [1]
C0270287
3. english as a second language
Beschreibung

ID.11

Datentyp

boolean

Alias
UMLS CUI [1]
C1546417
4. patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Beschreibung

ID.12

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0149660
UMLS CUI [1,3]
C1271966
5. known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
Beschreibung

ID.13

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0724680
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1320680
6. 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
Beschreibung

ID.14

Datentyp

boolean

Alias
UMLS CUI [1]
C2962753
7. 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
Beschreibung

ID.15

Datentyp

boolean

Alias
UMLS CUI [1]
C3500477
8. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
Beschreibung

ID.16

Datentyp

boolean

Alias
UMLS CUI [1]
C2585377
9. substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria
Beschreibung

ID.17

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0013146
10. opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrolment
Beschreibung

ID.18

Datentyp

boolean

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

ID.19

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0025519
UMLS CUI [1,3]
C0000854
UMLS CUI [1,4]
C1704711
UMLS CUI [1,5]
C2699704
12. unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
Beschreibung

ID.20

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
13. involvement in the planning and conduct of the study
Beschreibung

ID.21

Datentyp

boolean

Alias
UMLS CUI [1]
C0681871
14. previous enrolment or randomisation of treatment in the present study.
Beschreibung

ID.22

Datentyp

boolean

Alias
UMLS CUI [1]
C2347180
15. participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
Beschreibung

ID.23

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0586510
16. previous head injury, associated with loss of consciousness.
Beschreibung

ID.24

Datentyp

boolean

Alias
UMLS CUI [1]
C0018674
17. neurological disorder.
Beschreibung

ID.25

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
18. significant physical health problem
Beschreibung

ID.26

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
19. an absolute neutrophil count (anc) of 1.5 x 109 per liter;
Beschreibung

ID.27

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
20. a patient with diabetes mellitus (dm) fulfilling one of the following criteria:
Beschreibung

ID.28

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
unstable dm defined as enrollment glycosylated hemoglobin (hba1c) >8.5%.
Beschreibung

ID.29

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
admitted to hospital for treatment of dm or dm related illness in past 12 weeks.
Beschreibung

ID.30

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C4060672
not under physician care for dm
Beschreibung

ID.31

Datentyp

boolean

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

ID.32

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583348
UMLS CUI [1,2]
C0421258
physician responsible for patient's dm care has not approved patient's participation in the study. 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.
Beschreibung

ID.33

Datentyp

boolean

Alias
UMLS CUI [1]
C0359086
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 note: if a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
Beschreibung

ID.34

Datentyp

boolean

Alias
UMLS CUI [1]
C0745343
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Ähnliche Modelle

Eligibility Unipolar Depression NCT00517387

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
ID.2
Item
2. a diagnosis of unipolar depression by diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv-tr)
boolean
C0041696 (UMLS CUI [1])
ID.3
Item
3. females and males aged 19-65 years
boolean
C0001779 (UMLS CUI [1])
ID.4
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
C0009862 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
ID.5
Item
5. able to understand and comply with the requirements of the study
boolean
C1321605 (UMLS CUI [1])
ID.6
Item
6. minimum 21-item ham-d grid score of 15
boolean
C4273889 (UMLS CUI [1])
ID.7
Item
7. prior treatment with therapeutic doses of an ssri-type antidepressant for at least 6 weeks
boolean
C0360105 (UMLS CUI [1])
ID.8
Item
8. unsatisfactory response to treatment, as determined by clinician, for at least 6 weeks.
boolean
C0521982 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.9
Item
1. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.10
Item
2. any dsm-iv axis i disorder not defined in the inclusion criteria
boolean
C0270287 (UMLS CUI [1])
ID.11
Item
3. english as a second language
boolean
C1546417 (UMLS CUI [1])
ID.12
Item
4. 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 [1,1])
C0149660 (UMLS CUI [1,2])
C1271966 (UMLS CUI [1,3])
ID.13
Item
5. known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
boolean
C0724680 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1320680 (UMLS CUI [1,3])
ID.14
Item
6. 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
C2962753 (UMLS CUI [1])
ID.15
Item
7. 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
C3500477 (UMLS CUI [1])
ID.16
Item
8. administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
boolean
C2585377 (UMLS CUI [1])
ID.17
Item
9. substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria
boolean
C0085762 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
ID.18
Item
10. opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 4 weeks prior to enrolment
boolean
C0029095 (UMLS CUI [1,1])
C0236807 (UMLS CUI [1,2])
C0338700 (UMLS CUI [1,3])
C0009171 (UMLS CUI [1,4])
C0006868 (UMLS CUI [1,5])
C0018526 (UMLS CUI [1,6])
ID.19
Item
11. medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
boolean
C0012634 (UMLS CUI [1,1])
C0025519 (UMLS CUI [1,2])
C0000854 (UMLS CUI [1,3])
C1704711 (UMLS CUI [1,4])
C2699704 (UMLS CUI [1,5])
ID.20
Item
12. unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
boolean
C0012634 (UMLS CUI [1])
ID.21
Item
13. involvement in the planning and conduct of the study
boolean
C0681871 (UMLS CUI [1])
ID.22
Item
14. previous enrolment or randomisation of treatment in the present study.
boolean
C2347180 (UMLS CUI [1])
ID.23
Item
15. participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
boolean
C0008976 (UMLS CUI [1,1])
C0586510 (UMLS CUI [1,2])
ID.24
Item
16. previous head injury, associated with loss of consciousness.
boolean
C0018674 (UMLS CUI [1])
ID.25
Item
17. neurological disorder.
boolean
C0027765 (UMLS CUI [1])
ID.26
Item
18. significant physical health problem
boolean
C0012634 (UMLS CUI [1])
ID.27
Item
19. an absolute neutrophil count (anc) of 1.5 x 109 per liter;
boolean
C0948762 (UMLS CUI [1])
ID.28
Item
20. a patient with diabetes mellitus (dm) fulfilling one of the following criteria:
boolean
C0011849 (UMLS CUI [1])
ID.29
Item
unstable dm defined as enrollment glycosylated hemoglobin (hba1c) >8.5%.
boolean
C0019018 (UMLS CUI [1])
ID.30
Item
admitted to hospital for treatment of dm or dm related illness in past 12 weeks.
boolean
C0011849 (UMLS CUI [1,1])
C4060672 (UMLS CUI [1,2])
ID.31
Item
not under physician care for dm
boolean
C0583348 (UMLS CUI [1])
ID.32
Item
physician responsible for patient's dm care has not indicated that patient's dm is controlled.
boolean
C0583348 (UMLS CUI [1,1])
C0421258 (UMLS CUI [1,2])
ID.33
Item
physician responsible for patient's dm care has not approved patient's participation in the study. 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])
ID.34
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 note: if a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
boolean
C0745343 (UMLS CUI [1])
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