ID

38635

Description

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Keywords

Versions (1)
  1. 10/29/19 10/29/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 29, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

English

History of Major Depressive Disorder

1 forms  
MDD History
Description

MDD History

Alias
UMLS CUI-1
C1269683
UMLS CUI-2
C0262926
Chronic
Description

Major Depressive Disorder, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205191
With catatonic features
Description

Major Depressive Disorder, Catatonic phenomena

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0856959
With atypical features
Description

Major Depressive Disorder, Atypical

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205182
With melancholic features
Description

Major depressive disorder with melancholic features

Data type

boolean

Alias
UMLS CUI [1]
C1096724
With postpartum onset
Description

Major Depressive Disorder, Onset of, Postpartum Period

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0086839
With seasonal pattern (recurrent episode only)
Description

Major Depressive Disorder, Recurrent, Seasonal variation

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C0036496
Recurrent episode only: full interepisode recovery (full remission)?
Description

Major Depressive Disorder, Recurrent episode, Recovery

Data type

text

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0443287
UMLS CUI [1,3]
C2004454
Start date of current major depressive episode
Description

Major Depressive Disorder, Episode, Current, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C0808070
Duration of current major depressive episode
Description

Major Depressive Disorder, Episode, Current, Duration

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C0449238
weeks
Number of previous depressive episodes (not including current episode)
Description

Major Depressive Disorder, Episode, Previous, Quantity

Data type

text

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0205156
UMLS CUI [1,4]
C1265611
Start date of first depressive episode
Description

Major Depressive Disorder, Fist episode, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0439615
UMLS CUI [1,3]
C0808070
In the past, has the subject received pharmacotherapy, ECT, TMS or psychotherapy for depressive episodes?
Description

Major Depressive Disorder, Therapeutic procedure, In the past

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1444637
Has the subject received any treatment for the current episode?
Description

Major Depressive Disorder, Therapeutic procedure, Current

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0521116
Has the subject ever been hospitalized for major depressive disorder or other psychiatric condition?
Description

Major Depressive Disorder, Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0019993
Has the subject ever attempted suicide?
Description

Major Depressive Disorder, Suicide attempt

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0038663
Yes, indicate Number of attempts
Description

Major Depressive Disorder, Suicide attempt, Quantity

Data type

text

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0038663
UMLS CUI [1,3]
C1265611
Yes, indicate Date of most recent attempt
Description

Major Depressive Disorder, Suicide attempt, Recent, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0038663
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0011008
Do one or more first degree relatives (parents, siblings, children) of the subject have a history of major depressive disorder?
Description

Major Depressive Disorder, Family History

Data type

text

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0241889
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Similar models

History of Major Depressive Disorder

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MDD History
C1269683 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Major Depressive Disorder, Chronic
Item
Chronic
boolean
C1269683 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Major Depressive Disorder, Catatonic phenomena
Item
With catatonic features
boolean
C1269683 (UMLS CUI [1,1])
C0856959 (UMLS CUI [1,2])
Major Depressive Disorder, Atypical
Item
With atypical features
boolean
C1269683 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
Major depressive disorder with melancholic features
Item
With melancholic features
boolean
C1096724 (UMLS CUI [1])
Major Depressive Disorder, Onset of, Postpartum Period
Item
With postpartum onset
boolean
C1269683 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0086839 (UMLS CUI [1,3])
Major Depressive Disorder, Recurrent, Seasonal variation
Item
With seasonal pattern (recurrent episode only)
boolean
C1269683 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0036496 (UMLS CUI [1,3])
Item
Recurrent episode only: full interepisode recovery (full remission)?
text
C1269683 (UMLS CUI [1,1])
C0443287 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,3])
Major Depressive Disorder, Recurrent episode, Recovery
Code List
Recurrent episode only: full interepisode recovery (full remission)?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Major Depressive Disorder, Episode, Current, Start Date
Item
Start date of current major depressive episode
date
C1269683 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Major Depressive Disorder, Episode, Current, Duration
Item
Duration of current major depressive episode
integer
C1269683 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Item
Number of previous depressive episodes (not including current episode)
text
C1269683 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Major Depressive Disorder, Episode, Previous, Numbers
Code List
Number of previous depressive episodes (not including current episode)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 or more (4)
Major Depressive Disorder, Fist episode, Start Date
Item
Start date of first depressive episode
date
C1269683 (UMLS CUI [1,1])
C0439615 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Major Depressive Disorder, Therapeutic procedure, In the past
Item
In the past, has the subject received pharmacotherapy, ECT, TMS or psychotherapy for depressive episodes?
boolean
C1269683 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
Major Depressive Disorder, Therapeutic procedure, Current
Item
Has the subject received any treatment for the current episode?
boolean
C1269683 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Major Depressive Disorder, Hospitalization
Item
Has the subject ever been hospitalized for major depressive disorder or other psychiatric condition?
boolean
C1269683 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Major Depressive Disorder, Suicide attempt
Item
Has the subject ever attempted suicide?
boolean
C1269683 (UMLS CUI [1,1])
C0038663 (UMLS CUI [1,2])
Item
Yes, indicate Number of attempts
text
C1269683 (UMLS CUI [1,1])
C0038663 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Major Depressive Disorder, Suicide attempt, Quantity
Code List
Yes, indicate Number of attempts
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 or more (4)
Major Depressive Disorder, Suicide attempt, Recent, Date in time
Item
Yes, indicate Date of most recent attempt
date
C1269683 (UMLS CUI [1,1])
C0038663 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Do one or more first degree relatives (parents, siblings, children) of the subject have a history of major depressive disorder?
text
C1269683 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
Major Depressive Disorder, Family History
Code List
Do one or more first degree relatives (parents, siblings, children) of the subject have a history of major depressive disorder?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Suspected (3)
CL Item
Unknown (4)
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