ID

28906

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00337012

Stichworte

Versionen (1)
  1. 14.02.18 14.02.18 -
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See clinicaltrials.gov

Hochgeladen am

14. Februar 2018

DOI

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Eligibility Depressive Disorder NCT00337012

Englisch

Eligibility Depressive Disorder NCT00337012

1 Formulare  
Inclusion Criteria
Beschreibung

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)
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Major Depressive Disorder Hamilton rating scale for depression

Datentyp

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,
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Substance Use Disorders Absent Urine screening

Datentyp

boolean

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

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)
Beschreibung

Substance Use Disorders | Exception Nicotine Dependence

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Indication Organic brain disease | Indication Dementia | Indication Impaired cognition

Datentyp

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
Beschreibung

Substance Dependence | Exception Nicotine Dependence

Datentyp

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
Beschreibung

Medical condition Duloxetine Excluded

Datentyp

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.
Beschreibung

Hypersensitivity Duloxetine | Hypersensitivity Inactive ingredient

Datentyp

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.
Beschreibung

Monoamine Oxidase Inhibitors | Angle Closure Glaucoma Uncontrolled

Datentyp

boolean

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

Signs Hepatic Insufficiency

Datentyp

boolean

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

CYP1A2 Inhibitors | Fluvoxamine | Ciprofloxacin | Enoxacin

Datentyp

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)
Beschreibung

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

Datentyp

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]
Beschreibung

Subnormal intelligence IQ

Datentyp

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.
Beschreibung

Healthy Control Criteria Fulfill | Healthy Control Major Depressive Disorder Absent

Datentyp

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
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Ähnliche Modelle

Eligibility Depressive Disorder NCT00337012

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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