ID

29023

Description

A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Keywords

Versions (1)
  1. 2/21/18 2/21/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497

English

Visit 2 (Baseline)

1 forms  
  1. StudyEvent: ODM
    1. Visit 2 (Baseline)
HAM-D 17 IVRS prompt
Description

HAM-D 17 IVRS prompt

Alias
UMLS CUI-1
C3639712
Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
Description

----> If 'Yes', continue below ----> If 'No', the subject is not eligible to continue in this study.

Data type

boolean

If 'Yes', was the subject's HAM-D total score >=18 at this visit?
Description

If 'No', the subject is not eligible to continue in this study

Data type

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0449820
If 'Yes', did the subject’s HAM-D total score increase or decrease by more than 25% between the Screening and Baseline Visits?
Description

If 'Yes', the subject is not eligible to continue in this study.

Data type

boolean

Alias
UMLS CUI [1,1]
C3639712
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C1705241
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Height is recorded in cm. The following conversion factor must be used : inches x 2.54 = height in cm. Height is recorded to the nearest 1/2 cm.

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg.

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Baseline Adverse Events
Description

Baseline Adverse Events

Alias
UMLS CUI-1
C0877248
Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
Description

If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Description

Concomitant Medication Prompt

Alias
UMLS CUI-1
C2347852
Were there any changes in concomitant medication since the last visit?
Description

If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2169461
Urine dipstick pregnancy test
Description

Urine dipstick pregnancy test

Alias
UMLS CUI-1
C0430056
Was a urine dipstick performed?
Description

If subject is male or female subject is not of childbearing potential, please select Not Applicable below.

Data type

integer

Alias
UMLS CUI [1]
C0430056
Repeat 12-lead electrocardiogram prompt
Description

Repeat 12-lead electrocardiogram prompt

Alias
UMLS CUI-1
C0013798
UMLS CUI-2
C0205341
Was a repeat 12-Lead Electrocardiogram performed at this visit ?
Description

If 'Yes', please record on the Repeat 12-Lead Electrocardiogram panel.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Repeat Laboratory tests
Description

Repeat Laboratory tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0205341
Were repeat laboratory tests performed at this visit ?
Description

If 'Yes', please record on the Repeat Laboratory Tests panel.

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205341
Baseline Inclusion Criteria
Description

Baseline Inclusion Criteria

Did the subject meet all of the baseline inclusion criteria?
Description

If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.

Data type

boolean

Alias
UMLS CUI [1]
C1512693
Subject must have a HAM-D total score of >=18 at the Baseline Visit, as assessed via an Interactive Voice Response (IVR) rating system.
Description

HAM-D score

Data type

boolean

Alias
UMLS CUI [1]
C0451203
Subject must have a CGI Severity of Illness score of >=4 at the Baseline Visit.
Description

CGI Severity of Illness score

Data type

boolean

Alias
UMLS CUI [1]
C3639887
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Did the subject meet any of the exclusion criteria?
Description

If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Subject’s HAM-D total score increases or decreases by more than 25% between the Screening and Baseline visits.
Description

HAM-D total delta

Data type

boolean

Alias
UMLS CUI [1,1]
C0451203
UMLS CUI [1,2]
C0439097
Subject has taken any psychotropic drugs within 2 weeks prior to the Baseline Visit, including: - all antidepressants, including but not limited to monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), serotonin and noradrenaline reuptake inhibitors (SNRIs), noradrenaline and dopamine reuptake inhibitors (NDRIs), selective serotonin reuptake inhibitors (SSRIs) (with the exception of fluoxetine, for which the time period is 4 weeks prior to the Baseline Visit) - benzodiazepines, sedatives or hypnotics (except for zolpidem, zopiclone or zaleplon, which may be used sparingly, at the recommended dosage, for night time sedation up to two weeks after randomisation) - other psychoactive medications (including psychoactive herbal treatments, e.g. St. John's Wort).
Description

Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study

Data type

boolean

Alias
UMLS CUI [1]
C0033978
Subject has systolic blood pressure >=150 mmHg or diastolic blood pressure >=95 mmHg at the Baseline Visit.
Description

systolic blood pressure | diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
Subject continuation prompt
Description

Subject continuation prompt

Alias
UMLS CUI-1
C0805733
Is the subject continuing in the study?
Description

----> If 'No', please complete the Study Conclusion panel and any outstanding data. ----> If 'Yes', please: - Randomise the subject into the study via the IVR system. - Dispense allocated study medication packs to the subject. - Complete the Randomisation Number panel. - Schedule Visit 3 for 7 days (+/- 3 days) time.

Data type

boolean

Alias
UMLS CUI [1]
C0805733
Randomisation Number
Description

randomisation number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Record any additional comments related to this visit
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Visit 2 (Baseline)

1 forms
  1. StudyEvent: ODM
    1. Visit 2 (Baseline)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
HAM-D 17 IVRS prompt
C3639712 (UMLS CUI-1)
HAM-D 17
Item
Did the subject complete the HAM-D assessment at this visit via the Interactive Voice Response System (IVRS)?
boolean
HAM-D 17 total score
Item
If 'Yes', was the subject's HAM-D total score >=18 at this visit?
boolean
C3639712 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
HAM-D 17 score change
Item
If 'Yes', did the subject’s HAM-D total score increase or decrease by more than 25% between the Screening and Baseline Visits?
boolean
C3639712 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C1705241 (UMLS CUI [1,3])
Item Group
C0518766 (UMLS CUI-1)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C0428883 (UMLS CUI [1])
Item Group
Baseline Adverse Events
C0877248 (UMLS CUI-1)
adverse events
Item
Were there any adverse events observed or elicited by the following direct questions to the subject: "How are you feeling?" "Have you had any other medical problems since your last visit/assessment?"
boolean
C0877248 (UMLS CUI [1])
Item Group
Concomitant Medication Prompt
C2347852 (UMLS CUI-1)
concomitant medication changes
Item
Were there any changes in concomitant medication since the last visit?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
Item Group
C0430056 (UMLS CUI-1)
Item
Was a urine dipstick performed?
integer
C0430056 (UMLS CUI [1])
urine pregnancy test
Code List
Was a urine dipstick performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item Group
C0013798 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Repeated 12-lead EKG
Item
Was a repeat 12-Lead Electrocardiogram performed at this visit ?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
C0022885 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Repeat Laboratory tests
Item
Were repeat laboratory tests performed at this visit ?
boolean
C0022885 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item Group
Baseline Inclusion Criteria
Inclusion Criteria
Item
Did the subject meet all of the baseline inclusion criteria?
boolean
C1512693 (UMLS CUI [1])
HAM-D score
Item
Subject must have a HAM-D total score of >=18 at the Baseline Visit, as assessed via an Interactive Voice Response (IVR) rating system.
boolean
C0451203 (UMLS CUI [1])
CGI Severity of Illness score
Item
Subject must have a CGI Severity of Illness score of >=4 at the Baseline Visit.
boolean
C3639887 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
Exclusion Criteria
Item
Did the subject meet any of the exclusion criteria?
boolean
C0680251 (UMLS CUI [1])
HAM-D total delta
Item
Subject’s HAM-D total score increases or decreases by more than 25% between the Screening and Baseline visits.
boolean
C0451203 (UMLS CUI [1,1])
C0439097 (UMLS CUI [1,2])
psychotropic drugs
Item
Subject has taken any psychotropic drugs within 2 weeks prior to the Baseline Visit, including: - all antidepressants, including but not limited to monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), serotonin and noradrenaline reuptake inhibitors (SNRIs), noradrenaline and dopamine reuptake inhibitors (NDRIs), selective serotonin reuptake inhibitors (SSRIs) (with the exception of fluoxetine, for which the time period is 4 weeks prior to the Baseline Visit) - benzodiazepines, sedatives or hypnotics (except for zolpidem, zopiclone or zaleplon, which may be used sparingly, at the recommended dosage, for night time sedation up to two weeks after randomisation) - other psychoactive medications (including psychoactive herbal treatments, e.g. St. John's Wort).
boolean
C0033978 (UMLS CUI [1])
systolic blood pressure | diastolic blood pressure
Item
Subject has systolic blood pressure >=150 mmHg or diastolic blood pressure >=95 mmHg at the Baseline Visit.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Item Group
C0805733 (UMLS CUI-1)
subject continuing status
Item
Is the subject continuing in the study?
boolean
C0805733 (UMLS CUI [1])
randomisation number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Comments
Item
Record any additional comments related to this visit
text
C0947611 (UMLS CUI [1])
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