ID

28906

Beschrijving

The Effect of Duloxetine on Interoceptive Awareness; ODM derived from: https://clinicaltrials.gov/show/NCT00337012

Link

https://clinicaltrials.gov/show/NCT00337012

Trefwoorden

Versies (1)
  1. 14-02-18 14-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Depressive Disorder NCT00337012

Engels

Eligibility Depressive Disorder NCT00337012

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female (female are enrolled only under the condition of proof of using a safe and medially accepted contraceptive. according to the "note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" (cpmp/ich/286/95, modification) contraceptives with a pearl-index<1% are considered safe and effective. among these only hormonal contraceptives, micro-pill and tubal ligantions will be accepted in this study)
Beschrijving

Gender | Contraceptive Agents Safety Index | Contraceptives, Oral, Hormonal | Micro Pills Oral contraceptives | Tubal Ligation

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0009871
UMLS CUI [2,2]
C0036043
UMLS CUI [2,3]
C0918012
UMLS CUI [3]
C0009907
UMLS CUI [4,1]
C3811161
UMLS CUI [4,2]
C0994475
UMLS CUI [4,3]
C0029151
UMLS CUI [5]
C0520483
2. between the ages of 21 and 65 years; and
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. a diagnosis of major depression (hdrs>=15) and
Beschrijving

Major Depressive Disorder Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0451203
4. a minimum of 25 mm on a vas measure of painful symptoms (ranging from 0-100 mm), but no need for regular pain medication and hamd-17 item 13 minimum rated as 1,
Beschrijving

Symptoms Painful VAS | Analgesics Regular Redundant | Hamilton Depression Rating Scale 17 Item Questionnaire

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C0042815
UMLS CUI [2,1]
C0002771
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C1313915
UMLS CUI [3]
C3639712
5. medically and neurologically healthy on the basis of history, physical examination, ekg, screening laboratories (cbc w/ differential, tsh, free-t4, asat, alat, ggt, bun, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes) and
Beschrijving

Healthy Volunteers Medical Neurological | Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers Electrocardiography | Healthy Volunteers Laboratory Results | Complete blood count with differential | Thyroid stimulating hormone measurement | T4 free measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Calcium measurement | Phosphorus measurement | Magnesium measurement | Total protein measurement | Albumin measurement | Electrolytes measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0205494
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1708335
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C1708335
UMLS CUI [4,2]
C1623258
UMLS CUI [5,1]
C1708335
UMLS CUI [5,2]
C1254595
UMLS CUI [6]
C0545131
UMLS CUI [7]
C0202230
UMLS CUI [8]
C0202225
UMLS CUI [9]
C0201899
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0202035
UMLS CUI [12]
C0005845
UMLS CUI [13]
C0201976
UMLS CUI [14]
C0201925
UMLS CUI [15]
C0202178
UMLS CUI [16]
C0373675
UMLS CUI [17]
C0555903
UMLS CUI [18]
C0201838
UMLS CUI [19]
C0201992
6. absence of substance abuse on the basis of history and urine toxicology at screening.
Beschrijving

Substance Use Disorders Absent Urine screening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0595946
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. dsm-iv psychiatric and substance abuse diagnosis (excluding nicotine dependence) by history or psychiatric evaluation that includes a structured diagnostic interview for non-patient populations (scid-np)
Beschrijving

Substance Use Disorders | Exception Nicotine Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
2. current suicide risk sufficient to preclude treatment on an outpatient base: higher than "2" on the "suicide" item of hamd-17, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk.
Beschrijving

At risk for suicide Hamilton Depression Rating Scale 17 Item Questionnaire | Outpatient procedure Excluded | Suicide attempt | At risk Homicide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C3639712
UMLS CUI [2,1]
C1299353
UMLS CUI [2,2]
C0332196
UMLS CUI [3]
C0038663
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0019872
3. clinical indications of organic brain disease, dementia, or cognitive impairment.
Beschrijving

Indication Organic brain disease | Indication Dementia | Indication Impaired cognition

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1385010
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0497327
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0338656
4. history of substance dependence other than nicotine and consumption within the last year
Beschrijving

Substance Dependence | Exception Nicotine Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028043
5. any medical condition that would preclude the use of duloxetine treatment as
Beschrijving

Medical condition Duloxetine Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0245561
UMLS CUI [1,3]
C0332196
a known hypersensitivity to duloxetine or any of the inactive ingredients.
Beschrijving

Hypersensitivity Duloxetine | Hypersensitivity Inactive ingredient

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0245561
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1552019
intake of monoamine oxidase inhibitors (maois) or suffering from uncontrolled narrow-angle glaucoma.
Beschrijving

Monoamine Oxidase Inhibitors | Angle Closure Glaucoma Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2,1]
C0017605
UMLS CUI [2,2]
C0205318
signs of any hepatic insufficiency
Beschrijving

Signs Hepatic Insufficiency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1306571
intake of inhibitors of cyp1a2 (as fluvoxamine, ciprofloxacin, enoxacin)
Beschrijving

CYP1A2 Inhibitors | Fluvoxamine | Ciprofloxacin | Enoxacin

Datatype

boolean

Alias
UMLS CUI [1]
C3850068
UMLS CUI [2]
C0085228
UMLS CUI [3]
C0008809
UMLS CUI [4]
C0014310
end-stage renal disease (requiring dialysis) or severe renal impairment (estimated creatinine clearance [crcl] <30 ml/min)
Beschrijving

End-stage renal disease Requirement Dialysis | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2711451
6. subnormal intellectual potential as assessed by the wst-iq [metzler. und schmidt, 1992]
Beschrijving

Subnormal intelligence IQ

Datatype

boolean

Alias
UMLS CUI [1,1]
C2673906
UMLS CUI [1,2]
C0456149
healthy controls will meet exclusion and inclusion criteria, but will have no current or prior diagnosis of major depression.
Beschrijving

Healthy Control Criteria Fulfill | Healthy Control Major Depressive Disorder Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986479
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C2986479
UMLS CUI [2,2]
C1269683
UMLS CUI [2,3]
C0332197
Terug naar het begin van de pagina

Similar models

Eligibility Depressive Disorder NCT00337012

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Contraceptive Agents Safety Index | Contraceptives, Oral, Hormonal | Micro Pills Oral contraceptives | Tubal Ligation
Item
1. male and female (female are enrolled only under the condition of proof of using a safe and medially accepted contraceptive. according to the "note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" (cpmp/ich/286/95, modification) contraceptives with a pearl-index<1% are considered safe and effective. among these only hormonal contraceptives, micro-pill and tubal ligantions will be accepted in this study)
boolean
C0079399 (UMLS CUI [1])
C0009871 (UMLS CUI [2,1])
C0036043 (UMLS CUI [2,2])
C0918012 (UMLS CUI [2,3])
C0009907 (UMLS CUI [3])
C3811161 (UMLS CUI [4,1])
C0994475 (UMLS CUI [4,2])
C0029151 (UMLS CUI [4,3])
C0520483 (UMLS CUI [5])
Age
Item
2. between the ages of 21 and 65 years; and
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder Hamilton rating scale for depression
Item
3. a diagnosis of major depression (hdrs>=15) and
boolean
C1269683 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
Symptoms Painful VAS | Analgesics Regular Redundant | Hamilton Depression Rating Scale 17 Item Questionnaire
Item
4. a minimum of 25 mm on a vas measure of painful symptoms (ranging from 0-100 mm), but no need for regular pain medication and hamd-17 item 13 minimum rated as 1,
boolean
C1457887 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,3])
C0002771 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C1313915 (UMLS CUI [2,3])
C3639712 (UMLS CUI [3])
Healthy Volunteers Medical Neurological | Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers Electrocardiography | Healthy Volunteers Laboratory Results | Complete blood count with differential | Thyroid stimulating hormone measurement | T4 free measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gamma glutamyl transferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Calcium measurement | Phosphorus measurement | Magnesium measurement | Total protein measurement | Albumin measurement | Electrolytes measurement
Item
5. medically and neurologically healthy on the basis of history, physical examination, ekg, screening laboratories (cbc w/ differential, tsh, free-t4, asat, alat, ggt, bun, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes) and
boolean
C1708335 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0205494 (UMLS CUI [1,3])
C1708335 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1708335 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C1708335 (UMLS CUI [4,1])
C1623258 (UMLS CUI [4,2])
C1708335 (UMLS CUI [5,1])
C1254595 (UMLS CUI [5,2])
C0545131 (UMLS CUI [6])
C0202230 (UMLS CUI [7])
C0202225 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0202035 (UMLS CUI [11])
C0005845 (UMLS CUI [12])
C0201976 (UMLS CUI [13])
C0201925 (UMLS CUI [14])
C0202178 (UMLS CUI [15])
C0373675 (UMLS CUI [16])
C0555903 (UMLS CUI [17])
C0201838 (UMLS CUI [18])
C0201992 (UMLS CUI [19])
Substance Use Disorders Absent Urine screening
Item
6. absence of substance abuse on the basis of history and urine toxicology at screening.
boolean
C0038586 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0595946 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Substance Use Disorders | Exception Nicotine Dependence
Item
1. dsm-iv psychiatric and substance abuse diagnosis (excluding nicotine dependence) by history or psychiatric evaluation that includes a structured diagnostic interview for non-patient populations (scid-np)
boolean
C0038586 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
At risk for suicide Hamilton Depression Rating Scale 17 Item Questionnaire | Outpatient procedure Excluded | Suicide attempt | At risk Homicide
Item
2. current suicide risk sufficient to preclude treatment on an outpatient base: higher than "2" on the "suicide" item of hamd-17, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk.
boolean
C0563664 (UMLS CUI [1,1])
C3639712 (UMLS CUI [1,2])
C1299353 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0038663 (UMLS CUI [3])
C1444641 (UMLS CUI [4,1])
C0019872 (UMLS CUI [4,2])
Indication Organic brain disease | Indication Dementia | Indication Impaired cognition
Item
3. clinical indications of organic brain disease, dementia, or cognitive impairment.
boolean
C3146298 (UMLS CUI [1,1])
C1385010 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0497327 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0338656 (UMLS CUI [3,2])
Substance Dependence | Exception Nicotine Dependence
Item
4. history of substance dependence other than nicotine and consumption within the last year
boolean
C0038580 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028043 (UMLS CUI [2,2])
Medical condition Duloxetine Excluded
Item
5. any medical condition that would preclude the use of duloxetine treatment as
boolean
C3843040 (UMLS CUI [1,1])
C0245561 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Hypersensitivity Duloxetine | Hypersensitivity Inactive ingredient
Item
a known hypersensitivity to duloxetine or any of the inactive ingredients.
boolean
C0020517 (UMLS CUI [1,1])
C0245561 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1552019 (UMLS CUI [2,2])
Monoamine Oxidase Inhibitors | Angle Closure Glaucoma Uncontrolled
Item
intake of monoamine oxidase inhibitors (maois) or suffering from uncontrolled narrow-angle glaucoma.
boolean
C0026457 (UMLS CUI [1])
C0017605 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Signs Hepatic Insufficiency
Item
signs of any hepatic insufficiency
boolean
C0311392 (UMLS CUI [1,1])
C1306571 (UMLS CUI [1,2])
CYP1A2 Inhibitors | Fluvoxamine | Ciprofloxacin | Enoxacin
Item
intake of inhibitors of cyp1a2 (as fluvoxamine, ciprofloxacin, enoxacin)
boolean
C3850068 (UMLS CUI [1])
C0085228 (UMLS CUI [2])
C0008809 (UMLS CUI [3])
C0014310 (UMLS CUI [4])
End-stage renal disease Requirement Dialysis | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
end-stage renal disease (requiring dialysis) or severe renal impairment (estimated creatinine clearance [crcl] <30 ml/min)
boolean
C0022661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2711451 (UMLS CUI [3])
Subnormal intelligence IQ
Item
6. subnormal intellectual potential as assessed by the wst-iq [metzler. und schmidt, 1992]
boolean
C2673906 (UMLS CUI [1,1])
C0456149 (UMLS CUI [1,2])
Healthy Control Criteria Fulfill | Healthy Control Major Depressive Disorder Absent
Item
healthy controls will meet exclusion and inclusion criteria, but will have no current or prior diagnosis of major depression.
boolean
C2986479 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C2986479 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial