ID

30474

Description

A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia; ODM derived from: https://clinicaltrials.gov/show/NCT00435279

Link

https://clinicaltrials.gov/show/NCT00435279

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 NCT00435279

English

Eligibility Major Depressive Disorder NCT00435279

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects must have a primary diagnosis of major depressive disorder (mdd) by dsm-iv criteria (296.xx) as determined by the mini international neuropsychiatric interview (m.i.n.i.).
Description

Major Depressive Disorder Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332137
mdd must be the condition that was chiefly responsible for motivating the subject to seek treatment.
Description

Major Depressive Disorder Patient motivation Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0679856
UMLS CUI [1,3]
C0087111
subjects must have a 17-item hamilton depression scale (ham-d-17) total score of > 22 at the screening visit.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have a ham-d-17 total score < 18 at visit 2 will be discontinued from the study.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
all subjects who do not meet dsm-iv criteria (307.42) for insomnia related to a major depressive disorder.
Description

Absence Sleeplessness Relationship Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0917801
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C1269683
subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
Description

Time for rest and sleep Hour Quantity | Frequency per week Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1822180
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0439603
UMLS CUI [2,2]
C0332174
UMLS CUI [2,3]
C0449238
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Similar models

Eligibility Major Depressive Disorder NCT00435279

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder Principal diagnosis
Item
subjects must have a primary diagnosis of major depressive disorder (mdd) by dsm-iv criteria (296.xx) as determined by the mini international neuropsychiatric interview (m.i.n.i.).
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Major Depressive Disorder Patient motivation Therapeutic procedure
Item
mdd must be the condition that was chiefly responsible for motivating the subject to seek treatment.
boolean
C1269683 (UMLS CUI [1,1])
C0679856 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
subjects must have a 17-item hamilton depression scale (ham-d-17) total score of > 22 at the screening visit.
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
subjects who have a ham-d-17 total score < 18 at visit 2 will be discontinued from the study.
boolean
C3639712 (UMLS CUI [1])
Absence Sleeplessness Relationship Major Depressive Disorder
Item
all subjects who do not meet dsm-iv criteria (307.42) for insomnia related to a major depressive disorder.
boolean
C0332197 (UMLS CUI [1,1])
C0917801 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1269683 (UMLS CUI [1,4])
Time for rest and sleep Hour Quantity | Frequency per week Duration
Item
subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.
boolean
C1822180 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439603 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
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