ID

30447

Beschreibung

The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People; ODM derived from: https://clinicaltrials.gov/show/NCT00702598

Link

https://clinicaltrials.gov/show/NCT00702598

Stichworte

Versionen (2)
  1. 06.06.18 06.06.18 -
  2. 06.06.18 06.06.18 -
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See clinicaltrials.gov

Hochgeladen am

6. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Major Depressive Disorder (MDD) NCT00702598

Englisch

Eligibility Major Depressive Disorder (MDD) NCT00702598

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients aged 18-65 years.
Beschreibung

Outpatients | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients will meet dsm-iv criteria for major depressive disorder as determined by the mood disorders section of the mini international neuropsychiatric interview (mini, sheehan et al, 1998).
Beschreibung

Major Depressive Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study).
Beschreibung

Employed | Unemployment short-term

Datentyp

boolean

Alias
UMLS CUI [1]
C0557351
UMLS CUI [2,1]
C0041674
UMLS CUI [2,2]
C0443303
a score of 18 or greater on the self-rated version of the madrs, indicating at least moderately severe depression.
Beschreibung

Montgomery-Asberg Depression Rating Scale Questionnaire | Moderately severe depression | Severe depression

Datentyp

boolean

Alias
UMLS CUI [1]
C4054475
UMLS CUI [2]
C4304583
UMLS CUI [3]
C0588008
competency to give informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients on short-term (except for circumstances under inclusion criteria) or long-term disability.
Beschreibung

Disability short-term | Exception Circumstances Inclusion criteria | Disability Long-term

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0443303
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0680082
UMLS CUI [2,3]
C1512693
UMLS CUI [3,1]
C0231170
UMLS CUI [3,2]
C0443252
pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Sexually active Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0332197
serious suicidal risks as judged by the study doctor.
Beschreibung

At risk for suicide Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
the following dsm-iv diagnoses (to ensure a homogenous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid or delusional disorders; other psychotic disorders; panic disorder; generalized anxiety disorder; obsessive-compulsive disorder, or post traumatic stress disorder, if a primary diagnosis; bipolar disorder;bulimia nervosa; anorexia nervosa.
Beschreibung

Organic mental disorders | Substance Use Disorders | Substance Dependence | Schizophrenia | Paranoia | Delusional disorder | Psychotic Disorders | Panic Disorder | Generalized Anxiety Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Bipolar Disorder | Bulimia Nervosa | Anorexia Nervosa

Datentyp

boolean

Alias
UMLS CUI [1]
C0029227
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0038580
UMLS CUI [4]
C0036341
UMLS CUI [5]
C1456784
UMLS CUI [6]
C0011251
UMLS CUI [7]
C0033975
UMLS CUI [8]
C0030319
UMLS CUI [9]
C0270549
UMLS CUI [10]
C0028768
UMLS CUI [11]
C0038436
UMLS CUI [12]
C0005586
UMLS CUI [13]
C2267227
UMLS CUI [14]
C0003125
serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0018939
regular or current use of other psychotropic drugs.
Beschreibung

Psychotropic Drugs Regular | Psychotropic Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0033978
use of monoamine oxidase inhibitors within 14 days of visit 1, fluoxetine within 5 weeks of visit 1, and other antidepressants within 7 days of visit 1 (to ensure adequate drug washouts prior to starting escitalopram).
Beschreibung

Monoamine Oxidase Inhibitors | Fluoxetine | Antidepressive Agents | Washout

Datentyp

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0003289
UMLS CUI [4]
C1710661
previous use of escitalopram.
Beschreibung

Escitalopram

Datentyp

boolean

Alias
UMLS CUI [1]
C1099456
treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
Beschreibung

Depressive episode Unresponsive to Treatment | Antidepressive Agents Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of visit 1, or who plan to initiate such psychotherapy during this study.
Beschreibung

Psychotherapy | Cognitive Therapy | Interpersonal psychotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0033968
UMLS CUI [2]
C0009244
UMLS CUI [3]
C0871787
patients involved in any other form of treatment for depression.
Beschreibung

Therapeutic procedure Depressive disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011581
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Ähnliche Modelle

Eligibility Major Depressive Disorder (MDD) NCT00702598

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients aged 18-65 years.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder
Item
patients will meet dsm-iv criteria for major depressive disorder as determined by the mood disorders section of the mini international neuropsychiatric interview (mini, sheehan et al, 1998).
boolean
C1269683 (UMLS CUI [1])
Employed | Unemployment short-term
Item
currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study).
boolean
C0557351 (UMLS CUI [1])
C0041674 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
Montgomery-Asberg Depression Rating Scale Questionnaire | Moderately severe depression | Severe depression
Item
a score of 18 or greater on the self-rated version of the madrs, indicating at least moderately severe depression.
boolean
C4054475 (UMLS CUI [1])
C4304583 (UMLS CUI [2])
C0588008 (UMLS CUI [3])
Informed Consent
Item
competency to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disability short-term | Exception Circumstances Inclusion criteria | Disability Long-term
Item
patients on short-term (except for circumstances under inclusion criteria) or long-term disability.
boolean
C0231170 (UMLS CUI [1,1])
C0443303 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0680082 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C0231170 (UMLS CUI [3,1])
C0443252 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Childbearing Potential Sexually active Contraceptive methods Absent
Item
pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
At risk for suicide Serious
Item
serious suicidal risks as judged by the study doctor.
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Organic mental disorders | Substance Use Disorders | Substance Dependence | Schizophrenia | Paranoia | Delusional disorder | Psychotic Disorders | Panic Disorder | Generalized Anxiety Disorder | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Bipolar Disorder | Bulimia Nervosa | Anorexia Nervosa
Item
the following dsm-iv diagnoses (to ensure a homogenous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid or delusional disorders; other psychotic disorders; panic disorder; generalized anxiety disorder; obsessive-compulsive disorder, or post traumatic stress disorder, if a primary diagnosis; bipolar disorder;bulimia nervosa; anorexia nervosa.
boolean
C0029227 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038580 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C1456784 (UMLS CUI [5])
C0011251 (UMLS CUI [6])
C0033975 (UMLS CUI [7])
C0030319 (UMLS CUI [8])
C0270549 (UMLS CUI [9])
C0028768 (UMLS CUI [10])
C0038436 (UMLS CUI [11])
C0005586 (UMLS CUI [12])
C2267227 (UMLS CUI [13])
C0003125 (UMLS CUI [14])
Illness Serious Unstable | Heart Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | Nervous system disorder | Hematological Disease
Item
serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0018799 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
Psychotropic Drugs Regular | Psychotropic Drugs
Item
regular or current use of other psychotropic drugs.
boolean
C0033978 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2])
Monoamine Oxidase Inhibitors | Fluoxetine | Antidepressive Agents | Washout
Item
use of monoamine oxidase inhibitors within 14 days of visit 1, fluoxetine within 5 weeks of visit 1, and other antidepressants within 7 days of visit 1 (to ensure adequate drug washouts prior to starting escitalopram).
boolean
C0026457 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C1710661 (UMLS CUI [4])
Escitalopram
Item
previous use of escitalopram.
boolean
C1099456 (UMLS CUI [1])
Depressive episode Unresponsive to Treatment | Antidepressive Agents Quantity failed
Item
treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
boolean
C0349217 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Psychotherapy | Cognitive Therapy | Interpersonal psychotherapy
Item
patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of visit 1, or who plan to initiate such psychotherapy during this study.
boolean
C0033968 (UMLS CUI [1])
C0009244 (UMLS CUI [2])
C0871787 (UMLS CUI [3])
Therapeutic procedure Depressive disorder
Item
patients involved in any other form of treatment for depression.
boolean
C0087111 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
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