ID

30447

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00702598

Nyckelord

Versioner (2)
  1. 2018-06-06 2018-06-06 -
  2. 2018-06-06 2018-06-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 juni 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Major Depressive Disorder (MDD) NCT00702598

Engelsk

Eligibility Major Depressive Disorder (MDD) NCT00702598

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Outpatients | Age

Datatyp

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).
Beskrivning

Major Depressive Disorder

Datatyp

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).
Beskrivning

Employed | Unemployment short-term

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

At risk for suicide Serious

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Illness Serious Unstable | Heart 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 [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.
Beskrivning

Psychotropic Drugs Regular | Psychotropic Drugs

Datatyp

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).
Beskrivning

Monoamine Oxidase Inhibitors | Fluoxetine | Antidepressive Agents | Washout

Datatyp

boolean

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

Escitalopram

Datatyp

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.
Beskrivning

Depressive episode Unresponsive to Treatment | Antidepressive Agents Quantity failed

Datatyp

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.
Beskrivning

Psychotherapy | Cognitive Therapy | Interpersonal psychotherapy

Datatyp

boolean

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

Therapeutic procedure Depressive disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0011581
Tillbaka till toppen

Similar models

Eligibility Major Depressive Disorder (MDD) NCT00702598

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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