ID

21822

Descrizione

Assessment of Cognitive Functioning Before and After Treatment With Duloxetine; ODM derived from: https://clinicaltrials.gov/show/NCT00933439

collegamento

https://clinicaltrials.gov/show/NCT00933439

Keywords

versioni (1)
  1. 02/05/17 02/05/17 -
Caricato su

2 maggio 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00933439

Inglese

Eligibility Major Depressive Disorder NCT00933439

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability and willingness to provide written informed consent
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
primary diagnosis of major depressive disorder (mdd)
Descrizione

Major Depressive Disorder Primary

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205225
age 18-45
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
screening and baseline hamilton rating scale for depression (hrsd) 17-item score greater than or equal to 16 or clinical global impression (cgi) score of at least 4
Descrizione

Hamilton Depression Rating Scale 17 Item Questionnaire | Clinical Global Impression Questionnaire

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3639708
subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the inventory for depressive symptomatology (ids-c(30)) item addressing this symptom (#16: concentration and decision making)
Descrizione

Impaired cognition | Concentration ability impaired

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C0858201
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination
Descrizione

Comorbidity Laboratory Procedures | Comorbidity Information Physician | Comorbidity Evidence Physical Examination

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1533716
UMLS CUI [2,3]
C0031831
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0031809
patient report or evidence (based on physical examination or laboratory tests) of existing liver disease
Descrizione

Liver disease Patient report | Liver disease Evidence Physical Examination | Liver disease Evidence Laboratory Procedures

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0747307
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C3887511
UMLS CUI [3,3]
C0022885
presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine
Descrizione

Mental disorders | Depressive disorder Due to Comorbidity | Suicidal | High suicide risk | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia | Obsessive-Compulsive Disorder | Substance Use Disorders | Medical contraindication Relative Duloxetine | Medical contraindication Absolute Duloxetine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0009488
UMLS CUI [3]
C0438696
UMLS CUI [4]
C1271074
UMLS CUI [5]
C0033975
UMLS CUI [6]
C0853193
UMLS CUI [7]
C0236788
UMLS CUI [8]
C0005586
UMLS CUI [9]
C0036341
UMLS CUI [10]
C0036337
UMLS CUI [11]
C0003123
UMLS CUI [12]
C0006370
UMLS CUI [13]
C0028768
UMLS CUI [14]
C0038586
UMLS CUI [15,1]
C1301624
UMLS CUI [15,2]
C0205345
UMLS CUI [15,3]
C0245561
UMLS CUI [16,1]
C1301624
UMLS CUI [16,2]
C0205344
UMLS CUI [16,3]
C0245561
concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor
Descrizione

Pharmacotherapy | Psychotherapy | Antidepressive Agents | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizer | Cognitive Therapy | Medical contraindication duloxetine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0033968
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0040616
UMLS CUI [5]
C0040615
UMLS CUI [6]
C2917435
UMLS CUI [7]
C0009244
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0245561
hospitalization for mental illness within the past year
Descrizione

Hospitalization Mental disorder

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0004936
not fluent in spoken and written english
Descrizione

Ability to speak fluently English Language | Able to write English Language

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0564240
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding
Descrizione

Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
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Similar models

Eligibility Major Depressive Disorder NCT00933439

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability and willingness to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Major Depressive Disorder Primary
Item
primary diagnosis of major depressive disorder (mdd)
boolean
C1269683 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Age
Item
age 18-45
boolean
C0001779 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire | Clinical Global Impression Questionnaire
Item
screening and baseline hamilton rating scale for depression (hrsd) 17-item score greater than or equal to 16 or clinical global impression (cgi) score of at least 4
boolean
C3639712 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
Impaired cognition | Concentration ability impaired
Item
subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the inventory for depressive symptomatology (ids-c(30)) item addressing this symptom (#16: concentration and decision making)
boolean
C0338656 (UMLS CUI [1])
C0858201 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Laboratory Procedures | Comorbidity Information Physician | Comorbidity Evidence Physical Examination
Item
presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination
boolean
C0009488 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C0031831 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
Liver disease Patient report | Liver disease Evidence Physical Examination | Liver disease Evidence Laboratory Procedures
Item
patient report or evidence (based on physical examination or laboratory tests) of existing liver disease
boolean
C0023895 (UMLS CUI [1,1])
C0747307 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
Mental disorders | Depressive disorder Due to Comorbidity | Suicidal | High suicide risk | Psychotic Disorders | Bipolar I disorder | Bipolar II disorder | Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Anorexia | Bulimia | Obsessive-Compulsive Disorder | Substance Use Disorders | Medical contraindication Relative Duloxetine | Medical contraindication Absolute Duloxetine
Item
presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine
boolean
C0004936 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
C0438696 (UMLS CUI [3])
C1271074 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0853193 (UMLS CUI [6])
C0236788 (UMLS CUI [7])
C0005586 (UMLS CUI [8])
C0036341 (UMLS CUI [9])
C0036337 (UMLS CUI [10])
C0003123 (UMLS CUI [11])
C0006370 (UMLS CUI [12])
C0028768 (UMLS CUI [13])
C0038586 (UMLS CUI [14])
C1301624 (UMLS CUI [15,1])
C0205345 (UMLS CUI [15,2])
C0245561 (UMLS CUI [15,3])
C1301624 (UMLS CUI [16,1])
C0205344 (UMLS CUI [16,2])
C0245561 (UMLS CUI [16,3])
Pharmacotherapy | Psychotherapy | Antidepressive Agents | Anti-Anxiety Agents | Antipsychotic Agents | Mood Stabilizer | Cognitive Therapy | Medical contraindication duloxetine
Item
concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor
boolean
C0013216 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0040616 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
C2917435 (UMLS CUI [6])
C0009244 (UMLS CUI [7])
C1301624 (UMLS CUI [8,1])
C0245561 (UMLS CUI [8,2])
Hospitalization Mental disorder
Item
hospitalization for mental illness within the past year
boolean
C0019993 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Ability to speak fluently English Language | Able to write English Language
Item
not fluent in spoken and written english
boolean
C0564240 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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