Engelsk

Eligibility Major Depressive Disorder NCT00824044

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects will be adults, ages 18 to 75 years.
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
mdd, current according to the fourth version of the diagnostic and statistical manual for mental disorders (dsm-iv)
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
17-item hamilton depression rating scale (ham-d-17) score of > 14 at baseline.
Beskrivning

Hamilton Depression Rating Scale 17 Item Clinical Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
subjects who are not currently taking any antidepressant or other psychotropic medications and who have been free of these medications for 4 weeks prior to screening visit.
Beskrivning

Antidepressive Agents Free of | Psychotropic Drugs Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C0332296
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant, lactating, or planning a pregnancy during the study.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
Beskrivning

Childbearing Potential Contraceptive methods Absent | Oral contraception | Contraceptive implant | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Tubal Ligation | Partner had vasectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0029151
UMLS CUI [3]
C1657106
UMLS CUI [4]
C0221829
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0520483
UMLS CUI [9]
C0420842
any uncontrolled psychiatric disorder.
Beskrivning

Mental disorders Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205318
current use of psychotropic medications.
Beskrivning

Psychotropic Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0033978
psychotic features in the current episode or a history of psychotic features.
Beskrivning

Feature Psychotic Depressive episode | Feature Psychotic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348519
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0349217
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0033975
alcohol or substance abuse or dependence within the past three months.
Beskrivning

Substance Use Disorders | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
history of head trauma or seizure disorder.
Beskrivning

Craniocerebral Trauma | Epilepsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2]
C0014544
history of intolerance of the study medication.
Beskrivning

Intolerance to Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013230
failure to respond to escitalopram up to 20 mg for at least 6 weeks.
Beskrivning

Escitalopram Dosage | Disease Response failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1099456
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a therapeutic dose, equivalent to fluoxetine 40mg) in the current episode.
Beskrivning

Antidepressant therapy Dose Quantity | Fluoxetine Dose Equivalent | Depressive episode Response failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0016365
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205163
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C1704632
UMLS CUI [3,3]
C0231175
currently enrolled in other depression-focused psychotherapy and unwilling to cease treatment.
Beskrivning

Study Subject Participation Status | Psychotherapy Relationship Depression | Therapeutic procedure Discontinue Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0033968
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0011570
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
subjects who, per clinical judgment, are not appropriate candidates for cbt or ssris.
Beskrivning

Study Subject Inappropriate Cognitive Therapy | Study Subject Inappropriate Selective Serotonin Reuptake Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0009244
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0360105
history or current diagnosis of the following dsm-iv psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 3 months.
Beskrivning

Mental disorders | Organic mental disorder | Schizophrenia | Schizoaffective Disorder | Delusional disorder | Psychotic Disorders | Bipolar Disorder | Feature Psychotic Mood Congruent | Feature Psychotic Mood Incongruent | Substance Dependence

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0029227
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0011251
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0005586
UMLS CUI [8,1]
C2348519
UMLS CUI [8,2]
C0033975
UMLS CUI [8,3]
C0026516
UMLS CUI [8,4]
C0439853
UMLS CUI [9,1]
C2348519
UMLS CUI [9,2]
C0033975
UMLS CUI [9,3]
C0026516
UMLS CUI [9,4]
C1321310
UMLS CUI [10]
C0038580
serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the ham-d.
Beskrivning

At risk for suicide Serious Hamilton rating scale for depression | At risk Homicide Serious Hamilton rating scale for depression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0451203
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0019872
UMLS CUI [2,3]
C0205404
UMLS CUI [2,4]
C0451203
serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Beskrivning

Illness Serious | Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
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
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Similar models

Eligibility Major Depressive Disorder NCT00824044

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
subjects will be adults, ages 18 to 75 years.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder
Item
mdd, current according to the fourth version of the diagnostic and statistical manual for mental disorders (dsm-iv)
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
17-item hamilton depression rating scale (ham-d-17) score of > 14 at baseline.
boolean
C3639712 (UMLS CUI [1])
Antidepressive Agents Free of | Psychotropic Drugs Free of
Item
subjects who are not currently taking any antidepressant or other psychotropic medications and who have been free of these medications for 4 weeks prior to screening visit.
boolean
C0003289 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, lactating, or planning a pregnancy during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Childbearing Potential Contraceptive methods Absent | Oral contraception | Contraceptive implant | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Tubal Ligation | Partner had vasectomy
Item
women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0029151 (UMLS CUI [2])
C1657106 (UMLS CUI [3])
C0221829 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0520483 (UMLS CUI [8])
C0420842 (UMLS CUI [9])
Mental disorders Uncontrolled
Item
any uncontrolled psychiatric disorder.
boolean
C0004936 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Psychotropic Drugs
Item
current use of psychotropic medications.
boolean
C0033978 (UMLS CUI [1])
Feature Psychotic Depressive episode | Feature Psychotic
Item
psychotic features in the current episode or a history of psychotic features.
boolean
C2348519 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0349217 (UMLS CUI [1,3])
C2348519 (UMLS CUI [2,1])
C0033975 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
alcohol or substance abuse or dependence within the past three months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Craniocerebral Trauma | Epilepsy
Item
history of head trauma or seizure disorder.
boolean
C0018674 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Intolerance to Investigational New Drugs
Item
history of intolerance of the study medication.
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Escitalopram Dosage | Disease Response failed
Item
failure to respond to escitalopram up to 20 mg for at least 6 weeks.
boolean
C1099456 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Antidepressant therapy Dose Quantity | Fluoxetine Dose Equivalent | Depressive episode Response failed
Item
failure to respond to 2 or more adequate antidepressant trials (6 weeks or longer on a therapeutic dose, equivalent to fluoxetine 40mg) in the current episode.
boolean
C1096649 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0016365 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0349217 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Study Subject Participation Status | Psychotherapy Relationship Depression | Therapeutic procedure Discontinue Unwilling
Item
currently enrolled in other depression-focused psychotherapy and unwilling to cease treatment.
boolean
C2348568 (UMLS CUI [1])
C0033968 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0011570 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Study Subject Inappropriate Cognitive Therapy | Study Subject Inappropriate Selective Serotonin Reuptake Inhibitors
Item
subjects who, per clinical judgment, are not appropriate candidates for cbt or ssris.
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0009244 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0360105 (UMLS CUI [2,3])
Mental disorders | Organic mental disorder | Schizophrenia | Schizoaffective Disorder | Delusional disorder | Psychotic Disorders | Bipolar Disorder | Feature Psychotic Mood Congruent | Feature Psychotic Mood Incongruent | Substance Dependence
Item
history or current diagnosis of the following dsm-iv psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 3 months.
boolean
C0004936 (UMLS CUI [1])
C0029227 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0011251 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0005586 (UMLS CUI [7])
C2348519 (UMLS CUI [8,1])
C0033975 (UMLS CUI [8,2])
C0026516 (UMLS CUI [8,3])
C0439853 (UMLS CUI [8,4])
C2348519 (UMLS CUI [9,1])
C0033975 (UMLS CUI [9,2])
C0026516 (UMLS CUI [9,3])
C1321310 (UMLS CUI [9,4])
C0038580 (UMLS CUI [10])
At risk for suicide Serious Hamilton rating scale for depression | At risk Homicide Serious Hamilton rating scale for depression
Item
serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the ham-d.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0451203 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C0019872 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0451203 (UMLS CUI [2,4])
Illness Serious | Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease
Item
serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (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])
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