ID

19545

Description

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00296699

Link

https://clinicaltrials.gov/show/NCT00296699

Keywords

Versions (1)
  1. 1/8/17 1/8/17 -
Uploaded on

January 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atypical Depression NCT00296699

English

Eligibility Atypical Depression NCT00296699

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
dsm-iv major depression or dysthymia with atypical features
Description

Major Depressive Disorder | dysthymia with atypical features

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C4064351
age 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
physically healthy
Description

Healthy

Data type

boolean

Alias
UMLS CUI [1]
C3898900
hamd(24) > 14
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior experience with duloxetine
Description

duloxetine Received

Data type

boolean

Alias
UMLS CUI [1,1]
C0245561
UMLS CUI [1,2]
C1514756
history of psychosis or bipolar disorder, borderline personality disorder
Description

Psychotic Disorders | Bipolar Disorder | Borderline Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0006012
unstable medical disorder; any history of epilepsy
Description

Disease Unstable | Epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0014544
currently taking medication that can interact with duloxetine
Description

Pharmaceutical Preparation Interaction duloxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0245561
current (past six months) substance use disorder (illicit drugs and/or alcohol)
Description

Substance Use Disorders | Illicit drug use

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0281875
serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
Description

Feeling suicidal Serious | Hospitalization Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0686904
current (past two weeks) use of psychoactive medication (four weeks for fluoxetine)
Description

Psychotropic Drugs | Fluoxetine

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0016365
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
currently breast feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
fecund women failing to use acceptable birth control
Description

Childbearing Potential Contraceptive methods failing

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0231175
refractory depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 pdr maximum dose for at least 4 weeks] during current episode)
Description

Depressive Disorder, Treatment-Resistant | Antidepressive Agents Dose Maximum failed

Data type

boolean

Alias
UMLS CUI [1]
C2063866
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0806909
UMLS CUI [2,4]
C0231175
serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to icu, any duration of coma)
Description

Feeling suicidal Serious | Suicidal behavior | Suicide attempt Lifetime | Admission to intensive care unit | Coma Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C1760428
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C4071830
UMLS CUI [4]
C0583239
UMLS CUI [5,1]
C0009421
UMLS CUI [5,2]
C0449238
currently taking medication deemed effective
Description

Pharmaceutical Preparations Effective

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280519
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Similar models

Eligibility Atypical Depression NCT00296699

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | dysthymia with atypical features
Item
dsm-iv major depression or dysthymia with atypical features
boolean
C1269683 (UMLS CUI [1])
C4064351 (UMLS CUI [2])
Age
Item
age 18-65
boolean
C0001779 (UMLS CUI [1])
Healthy
Item
physically healthy
boolean
C3898900 (UMLS CUI [1])
Hamilton rating scale for depression
Item
hamd(24) > 14
boolean
C0451203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
duloxetine Received
Item
prior experience with duloxetine
boolean
C0245561 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
Psychotic Disorders | Bipolar Disorder | Borderline Personality Disorder
Item
history of psychosis or bipolar disorder, borderline personality disorder
boolean
C0033975 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0006012 (UMLS CUI [3])
Disease Unstable | Epilepsy
Item
unstable medical disorder; any history of epilepsy
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
Pharmaceutical Preparation Interaction duloxetine
Item
currently taking medication that can interact with duloxetine
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0245561 (UMLS CUI [1,3])
Substance Use Disorders | Illicit drug use
Item
current (past six months) substance use disorder (illicit drugs and/or alcohol)
boolean
C0038586 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
Feeling suicidal Serious | Hospitalization Patient need for
Item
serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Psychotropic Drugs | Fluoxetine
Item
current (past two weeks) use of psychoactive medication (four weeks for fluoxetine)
boolean
C0033978 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
currently breast feeding
boolean
C0006147 (UMLS CUI [1])
Childbearing Potential Contraceptive methods failing
Item
fecund women failing to use acceptable birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Depressive Disorder, Treatment-Resistant | Antidepressive Agents Dose Maximum failed
Item
refractory depression (defined as failure to respond to one or more adequate trials of marketed antidepressants [i.e., >=2/3 pdr maximum dose for at least 4 weeks] during current episode)
boolean
C2063866 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Feeling suicidal Serious | Suicidal behavior | Suicide attempt Lifetime | Admission to intensive care unit | Coma Duration
Item
serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to icu, any duration of coma)
boolean
C0424000 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2])
C0038663 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0583239 (UMLS CUI [4])
C0009421 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Pharmaceutical Preparations Effective
Item
currently taking medication deemed effective
boolean
C0013227 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
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