ID

29023

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-02-18 21-02-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 februari 2018

DOI

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Licentie

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

Engels

Visit 2 (Baseline)

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

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)?
Beschrijving

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

Datatype

boolean

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

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

Datatype

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?
Beschrijving

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

Datatype

boolean

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschrijving

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.

Datatype

float

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

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

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood Pressure Systolic
Beschrijving

Blood Pressure Systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Baseline Adverse Events
Beschrijving

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?"
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Concomitant Medication Prompt
Beschrijving

Concomitant Medication Prompt

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

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.

Datatype

boolean

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

Urine dipstick pregnancy test

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

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

Datatype

integer

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

Repeat 12-lead electrocardiogram prompt

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

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

Datatype

boolean

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

Repeat Laboratory tests

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

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

Datatype

boolean

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

Baseline Inclusion Criteria

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

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

Datatype

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.
Beschrijving

HAM-D score

Datatype

boolean

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

CGI Severity of Illness score

Datatype

boolean

Alias
UMLS CUI [1]
C3639887
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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.
Beschrijving

HAM-D total delta

Datatype

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).
Beschrijving

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

Datatype

boolean

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

systolic blood pressure | diastolic blood pressure

Datatype

boolean

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

Subject continuation prompt

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

----> 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.

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
Randomisation Number
Beschrijving

randomisation number

Datatype

integer

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

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Visit 2 (Baseline)

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 2 (Baseline)
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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