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Title

Hamilton Depression Rating Scale 17-Item (HAMD 17)

CDISC Reference

Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

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QRS Short Name

HAMD 17

QRS Permission Status

Public Domain

Team

Major Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam

Supplement Version

2.1

Status

REVISION DRAFT

Date

2023-09-0710

Notes

This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

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Date	Version	Summary of Changes
2023-09-0710	2.1 Draft	The HAMD 17 v2.0 supplement was updated to the wiki Clinical Classifications supplement template. Annotated CRF was revised to a CDISC CRF to avoid complications with HAMD 17 CRFs included in copyrighted publications. The RSEVAL assumption and variable was removed from this supplement, because it is not captured on the CRF and no assumptions are made on the potential values. Section 3.1 reference to the total score of 54 was revised to 53. Revised assumption 2 to be a sponsor's stated evaluation interval. Added assumption 4 describing how items 16A and 16B are handled and included with the “logically skipped item” data rule. The example replaced the RSBLFL variable with RSLOBXFL, added the RSDTC variable, and uses the RSTAT and RSREASND variables for the unanswered item 16B. All responses were updated to end in a period (".") to reflect punctuation on the CRF. The following example row values were revised: Row 3 RSTESTCD = “HAMD103" original RSORRES = “Ideas or gestures suicide.” was revised to “Ideas or gestures of suicide.” Row 8 RSTESTCD = “HAMD108" original RSORRES = “Complete stupor.”, RSSTRESC = 4, and RSSTRESN = 4 was revised to RSORRES = “Slight retardation during the interview.”, RSSTRESC = 1, and RSSTRESN = 1. Updated the data example to include a missing visit 2 set of "NOT DONE" records for each item.
2016-05-23	2.0	This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
2013-05-15	1.1	Q16 only uses Part A or Part B and not both items Revised annotated CRF to meet annotation font standards
2012-08-07	1.0	Final

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The HAMD 17 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit and a visit 2 represented as not being collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.and

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visit 2 represented as not being collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in QSORRES.This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.

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The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

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Dataset wrap

Name	rs

Rowcaps

Jira
Row 16:	Represents item 16 Part A when the subject answered the weight loss according to the patient.
Row 17:	Represents item 16 Part B as a logically skipped item when the 16 Part A item is answered.
Row 19:	Represents the total score. All total scores are considered as captured data unless the sponsor operationally derives it via an EDC system.
Rows 20-38:	Show the subject was not evaluated on this instrument at visit 2. Because the reason for not completing the visit
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the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

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is assumed for when the visit would have occurred

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.

Dataset2

ROW

STUDYID

DOMAIN

USUBJID

RSSEQ

RSTESTCD

RSTEST

RSCAT

RSORRES

RSSTRESC

RSSTRESN

RSSTAT

RSREASND

RSLOBXFL

VISITNUM

RSDTC

RSEVLINT

1

STUDYX

RS

2324-P0001

1

HAMD101

HAMD1-Depressed Mood

HAMD 17

Absent.

0

Y

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1

2019-11-16

-P1W

2

STUDYX

RS

2324-P0001

2

HAMD102

HAMD1-Feelings of Guilt

HAMD 17

Self reproach, feels he/she has let people down.

1

Y

1

2019-11-16

-P1W

3

STUDYX

RS

2324-P0001

3

HAMD103

HAMD1-Suicide

HAMD 17

Ideas or gestures of suicide.

3

Y

1

2019-11-16

-P1W

4

STUDYX

RS

2324-P0001

4

HAMD104

HAMD1-Insomnia Early - Early Night

HAMD 17

No difficulty falling asleep.

0

Y

1

2019-11-16

-P1W

5

STUDYX

RS

2324-P0001

5

HAMD105

HAMD1-Insomnia Middle - Middle Night

HAMD 17

No difficulty.

0

Y

1

2019-11-16

-P1W

6

STUDYX

RS

2324-P0001

6

HAMD106

HAMD1-Insomnia Early Hours -Morning

HAMD 17

No difficulty.

0

Y

1

2019-11-16

-P1W

7

STUDYX

RS

2324-P0001

7

HAMD107

HAMD1-Work and Activities

HAMD 17

No difficulty.

0

Y

1

2019-11-16

-P1W

8

STUDYX

RS

2324-P0001

8

HAMD108

HAMD1-Retardation

HAMD 17

Slight retardation during the interview.

1

Y

1

2019-11-16

-P1W

9

STUDYX

RS

2324-P0001

9

HAMD109

HAMD1-Agitation

HAMD 17

Fidgetiness.

1

Y

1

2019-11-16

-P1W

10

STUDYX

RS

2324-P0001

10

HAMD110

HAMD1-Anxiety Psychic

HAMD 17

No difficulty.

0

Y

1

2019-11-16

-P1W

11

STUDYX

RS

2324-P0001

11

HAMD111

HAMD1-Anxiety Somatic

HAMD 17

Moderate.

2

Y

1

2019-11-16

-P1W

12

STUDYX

RS

2324-P0001

12

HAMD112

HAMD1-Somatic Symptoms Gastrointestinal

HAMD 17

None.

0

Y

1

2019-11-16

-P1W

13

STUDYX

RS

2324-P0001

13

HAMD113

HAMD1-General Somatic Symptoms

HAMD 17

None.

0

Y

1

2019-11-16

-P1W

14

STUDYX

RS

2324-P0001

14

HAMD114

HAMD1-Genital Symptoms

HAMD 17

Mild.

1

Y

1

2019-11-16

-P1W

15

STUDYX

RS

2324-P0001

15

HAMD115

HAMD1-Hypochondriasis

HAMD 17

Not present.

0

Y

1

2019-11-16

-P1W

16

STUDYX

RS

2324-P0001

16

HAMD116A

HAMD1-Loss of WT According to Patient

HAMD 17

Definite (according to patient) weight loss.

2

Y

1

2019-11-16

-P1W

17

STUDYX

RS

2324-P0001

17

HAMD116B

HAMD1-Loss of WT According to WK Meas

HAMD 17

NOT DONE

LOGICALLY SKIPPED ITEM

Y

1

2019-11-16

-P1W

18

STUDYX

RS

2324-P0001

18

HAMD117

HAMD1-Insight

HAMD 17

Denies being ill at all.

2

Y

1

2019-11-16

-P1W

19

STUDYX

RS

2324-P0001

19

HAMD118

HAMD1-Total Score

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HAMD 17

13

Y

1

2019-11-16

-P1W

20

STUDYX

RS

2324-P0001

20

HAMD101

HAMD1-Depressed Mood

HAMD 17

NOT DONE

2

21

STUDYX

RS

2324-P0001

21

HAMD102

HAMD1-Feelings of Guilt

HAMD 17

NOT DONE

2

22

STUDYX

RS

2324-P0001

22

HAMD103

HAMD1-Suicide

HAMD 17

NOT DONE

2

23

STUDYX

RS

2324-P0001

23

HAMD104

HAMD1-Insomnia Early - Early Night

HAMD 17

NOT DONE

2

24

STUDYX

RS

2324-P0001

24

HAMD105

HAMD1-Insomnia Middle - Middle Night

HAMD 17

NOT DONE

2

25

STUDYX

RS

2324-P0001

25

HAMD106

HAMD1-Insomnia Early Hours -Morning

HAMD 17

NOT DONE

2

26

STUDYX

RS

2324-P0001

26

HAMD107

HAMD1-Work and Activities

HAMD 17

NOT DONE

2

27

STUDYX

RS

2324-P0001

27

HAMD108

HAMD1-Retardation

HAMD 17

NOT DONE

2

28

STUDYX

RS

2324-P0001

28

HAMD109

HAMD1-Agitation

HAMD 17

NOT DONE

2

29

STUDYX

RS

2324-P0001

29

HAMD110

HAMD1-Anxiety Psychic

HAMD 17

NOT DONE

2

30

STUDYX

RS

2324-P0001

30

HAMD111

HAMD1-Anxiety Somatic

HAMD 17

NOT DONE

2

31

STUDYX

RS

2324-P0001

31

HAMD112

HAMD1-Somatic Symptoms Gastrointestinal

HAMD 17

NOT DONE

2

32

STUDYX

RS

2324-P0001

32

HAMD113

HAMD1-General Somatic Symptoms

HAMD 17

NOT DONE

2

33

STUDYX

RS

2324-P0001

33

HAMD114

HAMD1-Genital Symptoms

HAMD 17

NOT DONE

2

34

STUDYX

RS

2324-P0001

34

HAMD115

HAMD1-Hypochondriasis

HAMD 17

NOT DONE

2

35

STUDYX

RS

2324-P0001

35

HAMD116A

HAMD1-Loss of WT According to Patient

HAMD 17

NOT DONE

2

36

STUDYX

RS

2324-P0001

36

HAMD116B

HAMD1-Loss of WT According to WK Meas

HAMD 17

NOT DONE

2

37

STUDYX

RS

2324-P0001

37

HAMD117

HAMD1-Insight

HAMD 17

NOT DONE

2

38

STUDYX

RS

2324-P0001

38

HAMD118

HAMD1-Total Score

HAMD 17

NOT DONE

2

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