ID

15561

Beschreibung

Connectivity Affecting the Antidepressant REsponse Study; ODM derived from: https://clinicaltrials.gov/show/NCT02332291

Link

https://clinicaltrials.gov/show/NCT02332291

Stichworte

Versionen (2)
  1. 31.05.16 31.05.16 -
  2. 03.06.16 03.06.16 - Julian Varghese
Hochgeladen am

3. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02332291

Englisch

Eligibility Major Depressive Disorder NCT02332291

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 60 years or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. current diagnosis of major depressive disorder (dsm-iv-tr), single episode, recurrent or chronic, without psychotic features, as detected by mini and clinical exam.
Beschreibung

Major Depressive Disorder DSM-IV | Single major depressive episode | Major Depressive Disorder Recurrent | Major Depressive Disorder chronic | depression psychotic feature

Datentyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C2945760
UMLS CUI [4,1]
C1269683
UMLS CUI [4,2]
C0205191
UMLS CUI [5]
C0743076
3. minimum madrs score ≥ 15.
Beschreibung

Depressive disorder Rating scale | Minimum

Datentyp

boolean

Alias
UMLS CUI [1]
C4054475
4. mini-mental state exam ≥ 24.
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
5. fluent in english.
Beschreibung

Able to speak fluently English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current or past diagnoses of other axis i psychiatric disorders, except for generalized anxiety disorder (gad) symptoms occurring during a depressive episode
Beschreibung

Mental disorders Axis I diagnosis | Generalized Anxiety Disorder | Depressive episode

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0270287
UMLS CUI [2]
C0270549
UMLS CUI [3]
C0349217
2. history of alcohol or drug dependence or abuse in the last three years
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
3. history of developmental disorder or iq score < 70
Beschreibung

Developmental Disabilities | Intelligence quotient Score

Datentyp

boolean

Alias
UMLS CUI [1]
C0008073
UMLS CUI [2,1]
C0456149
UMLS CUI [2,2]
C0449820
4. presence of acute suicidality
Beschreibung

Suicidality acute

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3166387
UMLS CUI [1,2]
C0205178
5. acute grief (< 1 month)
Beschreibung

Grief acute

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018235
UMLS CUI [1,2]
C0205178
6. current or past psychosis
Beschreibung

Psychotic Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0033975
7. primary neurological disorder, including but not limited to dementia, stroke, brain tumors, epilepsy, parkinson's disease, or demyelinating diseases
Beschreibung

nervous system disorder | Dementia | Cerebrovascular accident | Brain Neoplasms | Epilepsy | Parkinson Disease | Demyelinating Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0006118
UMLS CUI [5]
C0014544
UMLS CUI [6]
C0030567
UMLS CUI [7]
C0011303
8. mri contraindications
Beschreibung

Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
9. any physical or intellectual disability adversely affecting ability to complete assessments
Beschreibung

Physical disability | Intellectual Disability | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C0520817
UMLS CUI [2]
C3714756
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
10. electroconvulsive therapy in last 6 months
Beschreibung

Electroconvulsive Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013806
11. use of antidepressant medications or other psychotropic medications in the last 4 weeks (or the last 6 weeks for fluoxetine). occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during this period is allowable.
Beschreibung

Antidepressive Agents | Psychotropic Drugs | Fluoxetine | Benzodiazepines | Sedative hypnotics (non-benzodiazepines) | zolpidem | Eszopiclone | zaleplon

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0033978
UMLS CUI [3]
C0016365
UMLS CUI [4]
C0005064
UMLS CUI [5]
C3854290
UMLS CUI [6]
C0078839
UMLS CUI [7]
C1436328
UMLS CUI [8]
C0251504
12. a failed therapeutic trial of escitalopram in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 10mg or higher)
Beschreibung

Depressive episode | Escitalopram Therapeutic Clinical Trial failed

Datentyp

boolean

Alias
UMLS CUI [1]
C0349217
UMLS CUI [2,1]
C1099456
UMLS CUI [2,2]
C1515364
UMLS CUI [2,3]
C0231175
13. known allergy or hypersensitivity to escitalopram or bupropion
Beschreibung

Hypersensitivity Escitalopram | Hypersensitivity Bupropion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0085208
14. current or planned psychotherapy
Beschreibung

Psychotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0033968
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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT02332291

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 60 years or older.
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder DSM-IV | Single major depressive episode | Major Depressive Disorder Recurrent | Major Depressive Disorder chronic | depression psychotic feature
Item
2. current diagnosis of major depressive disorder (dsm-iv-tr), single episode, recurrent or chronic, without psychotic features, as detected by mini and clinical exam.
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C1269683 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C1269683 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0743076 (UMLS CUI [5])
Depressive disorder Rating scale | Minimum
Item
3. minimum madrs score ≥ 15.
boolean
C4054475 (UMLS CUI [1])
Mini-mental state examination
Item
4. mini-mental state exam ≥ 24.
boolean
C0451306 (UMLS CUI [1])
Able to speak fluently English Language
Item
5. fluent in english.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Mental disorders Axis I diagnosis | Generalized Anxiety Disorder | Depressive episode
Item
1. current or past diagnoses of other axis i psychiatric disorders, except for generalized anxiety disorder (gad) symptoms occurring during a depressive episode
boolean
C0004936 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C0270549 (UMLS CUI [2])
C0349217 (UMLS CUI [3])
Substance Use Disorders | Substance Dependence
Item
2. history of alcohol or drug dependence or abuse in the last three years
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Developmental Disabilities | Intelligence quotient Score
Item
3. history of developmental disorder or iq score < 70
boolean
C0008073 (UMLS CUI [1])
C0456149 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Suicidality acute
Item
4. presence of acute suicidality
boolean
C3166387 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
Grief acute
Item
5. acute grief (< 1 month)
boolean
C0018235 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
Psychotic Disorders
Item
6. current or past psychosis
boolean
C0033975 (UMLS CUI [1])
nervous system disorder | Dementia | Cerebrovascular accident | Brain Neoplasms | Epilepsy | Parkinson Disease | Demyelinating Diseases
Item
7. primary neurological disorder, including but not limited to dementia, stroke, brain tumors, epilepsy, parkinson's disease, or demyelinating diseases
boolean
C0027765 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0006118 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0030567 (UMLS CUI [6])
C0011303 (UMLS CUI [7])
Medical contraindication Magnetic Resonance Imaging
Item
8. mri contraindications
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Physical disability | Intellectual Disability | Compliance behavior Limited
Item
9. any physical or intellectual disability adversely affecting ability to complete assessments
boolean
C0520817 (UMLS CUI [1])
C3714756 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
Electroconvulsive Therapy
Item
10. electroconvulsive therapy in last 6 months
boolean
C0013806 (UMLS CUI [1])
Antidepressive Agents | Psychotropic Drugs | Fluoxetine | Benzodiazepines | Sedative hypnotics (non-benzodiazepines) | zolpidem | Eszopiclone | zaleplon
Item
11. use of antidepressant medications or other psychotropic medications in the last 4 weeks (or the last 6 weeks for fluoxetine). occasional use of benzodiazepines or non-benzodiazepine sedatives (such as zolpidem, eszopiclone, or zaleplon) during this period is allowable.
boolean
C0003289 (UMLS CUI [1])
C0033978 (UMLS CUI [2])
C0016365 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C3854290 (UMLS CUI [5])
C0078839 (UMLS CUI [6])
C1436328 (UMLS CUI [7])
C0251504 (UMLS CUI [8])
Depressive episode | Escitalopram Therapeutic Clinical Trial failed
Item
12. a failed therapeutic trial of escitalopram in the current depressive episode (defined as at least 6 weeks of treatment at a daily dose of 10mg or higher)
boolean
C0349217 (UMLS CUI [1])
C1099456 (UMLS CUI [2,1])
C1515364 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Hypersensitivity Escitalopram | Hypersensitivity Bupropion
Item
13. known allergy or hypersensitivity to escitalopram or bupropion
boolean
C0020517 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0085208 (UMLS CUI [2,2])
Psychotherapy
Item
14. current or planned psychotherapy
boolean
C0033968 (UMLS CUI [1])
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