ID

30441

Description

Pilot Study of Duloxetine in Psychological Resilience; ODM derived from: https://clinicaltrials.gov/show/NCT00331799

Link

https://clinicaltrials.gov/show/NCT00331799

Keywords

Versions (1)
  1. 6/6/18 6/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00331799

English

Eligibility Major Depressive Disorder NCT00331799

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages 18-65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
primary diagnosis of mdd based on diagnostic standard manual(dsm-iv) criteria and assessed by the mini international neuropsychiatric interview
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
montgomery-asberg depression rating scale (madrs)score of at least 20 on baseline
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
minimum clinical global impressions of severity (cgs) severity score of 4
Description

Clinical global impression scale Severity score

Data type

boolean

Alias
UMLS CUI [1,1]
C3639708
UMLS CUI [1,2]
C0457451
ability to provide written consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
a negative serum pregnancy test for women of childbearing potential
Description

Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition
Description

Bipolar Disorder | Schizophrenia | Psychotic Disorders | Mental Retardation | Pervasive Development Disorder | Cognitive disorder due to general medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0025362
UMLS CUI [5]
C0524528
UMLS CUI [6]
C1392778
history of substance abuse or dependence within the last 6 months
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
suicide risk or serious suicide attempt within the last year
Description

At risk for suicide | Suicide attempt Serious

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C0205404
clinically significant medical condition or laboratory abnormality
Description

Medical condition Clinical Significance | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438215
women of childbearing potential who are unwilling to practice an acceptable method of contraception
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
subjects needing concurrent use of psychotropic medications
Description

Patient need for Psychotropic Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0033978
history of sensitivity to duloxetine
Description

Hypersensitivity Duloxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0245561
history of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks)
Description

Duloxetine U/day | Response failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0245561
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
subjects taking monoamine oxidase inhibitors (maois)
Description

Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0026457
subjects with uncontrolled narrow-angle glaucoma
Description

Angle Closure Glaucoma Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility Major Depressive Disorder NCT00331799

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages 18-65
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
primary diagnosis of mdd based on diagnostic standard manual(dsm-iv) criteria and assessed by the mini international neuropsychiatric interview
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
montgomery-asberg depression rating scale (madrs)score of at least 20 on baseline
boolean
C4054475 (UMLS CUI [1])
Clinical global impression scale Severity score
Item
minimum clinical global impressions of severity (cgs) severity score of 4
boolean
C3639708 (UMLS CUI [1,1])
C0457451 (UMLS CUI [1,2])
Informed Consent
Item
ability to provide written consent form
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
a negative serum pregnancy test for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder | Schizophrenia | Psychotic Disorders | Mental Retardation | Pervasive Development Disorder | Cognitive disorder due to general medical condition
Item
current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
C0025362 (UMLS CUI [4])
C0524528 (UMLS CUI [5])
C1392778 (UMLS CUI [6])
Substance Use Disorders | Substance Dependence
Item
history of substance abuse or dependence within the last 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
At risk for suicide | Suicide attempt Serious
Item
suicide risk or serious suicide attempt within the last year
boolean
C0563664 (UMLS CUI [1])
C0038663 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Medical condition Clinical Significance | Laboratory test result abnormal
Item
clinically significant medical condition or laboratory abnormality
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential who are unwilling to practice an acceptable method of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Patient need for Psychotropic Drugs
Item
subjects needing concurrent use of psychotropic medications
boolean
C0686904 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
Hypersensitivity Duloxetine
Item
history of sensitivity to duloxetine
boolean
C0020517 (UMLS CUI [1,1])
C0245561 (UMLS CUI [1,2])
Duloxetine U/day | Response failed
Item
history of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks)
boolean
C0245561 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Monoamine Oxidase Inhibitors
Item
subjects taking monoamine oxidase inhibitors (maois)
boolean
C0026457 (UMLS CUI [1])
Angle Closure Glaucoma Uncontrolled
Item
subjects with uncontrolled narrow-angle glaucoma
boolean
C0017605 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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