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Title | Hamilton Depression Rating Scale 17-Item (HAMD 17) |
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CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | Public Domain |
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Team | Major Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 2.1 |
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Status | REVISION DRAFT |
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Date | 2021-04-2426 |
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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 |
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2021-04-2426 | 2.1 Draft | |
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.
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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
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2012-08-07 | 1.0 | Final |
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The HAMD 17 is a multiple-choice instrument that clinicians may use to assess the severity of major depression. Max Hamilton originally published the scale in 1960 and reviewed and evaluated revised it in 1967, 1976, 1980, and 2005. The . The measure, which is designed for adult subjects, rates the severity of symptoms observed in depression (e.g., low mood, insomnia, agitation, anxiety, weight loss). It consists of 17 items, each rated on a 3-, 4-, or 5-point scale. A total score between 0-53 is also captured.
The scale points include a numeric rating (0-2, 0-3, or 0-4) and a definition of what is represented by the rating (e.g., 0 = "Absent.", 4 = "Incapacitating."). For the HAMD 17, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
The time period of evaluation for the the HAMD 17 is populated in the RSEVLINT field as an evaluation interval text value, since it cannot variable in ISO 8601 format when the evaluation interval can be precisely described as an ISO 8601 duration. The evaluation interval for the HAMD 17 is determined based on the sponsor's stated evaluation interval.
The HAMD 17 instrument includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below. This score may be submitted in SDTM or derived in the Analysis Data Model (ADaM).
If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).
- if scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
Item 16 contains 2 components: Part A, which is loss of weight according to the patient and Part B, which is loss of weight according to weekly measurements. Only 1 of these items is answered when administering the HAMD 17 instrument. A record is created in rs.xpt for all items. The unanswered component is considered as a logically skipped item in the data and is represented as follows:
RSSTAT = "NOT DONE".
RSREASND = "LOGICALLY SKIPPED ITEM".
RSORRES, RSSTRESC, and RSSTRESN are set to null.
Terminology
RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.
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Dataset wrap |
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Rowcaps |
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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: | Represent all items are missing since the instrument was not filled out at visit 2. |
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Dataset2 |
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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 | 0 |
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| Y | 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 | 1 |
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| Y | 1 | 2019-11-16 | -P1W | 3 | STUDYX | RS | 2324-P0001 | 3 | HAMD103 | HAMD1-Suicide | HAMD 17 | Ideas or gestures of suicide. | 3 | 3 |
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| 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 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 5 | STUDYX | RS | 2324-P0001 | 5 | HAMD105 | HAMD1-Insomnia Middle - Middle Night | HAMD 17 | No difficulty. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 6 | STUDYX | RS | 2324-P0001 | 6 | HAMD106 | HAMD1-Insomnia Early Hours -Morning | HAMD 17 | No difficulty. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 7 | STUDYX | RS | 2324-P0001 | 7 | HAMD107 | HAMD1-Work and Activities | HAMD 17 | No difficulty. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 8 | STUDYX | RS | 2324-P0001 | 8 | HAMD108 | HAMD1-Retardation | HAMD 17 | Slight retardation during the interview. | 1 | 1 |
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| Y | 1 | 2019-11-16 | -P1W | 9 | STUDYX | RS | 2324-P0001 | 9 | HAMD109 | HAMD1-Agitation | HAMD 17 | Fidgetiness. | 1 | 1 |
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| Y | 1 | 2019-11-16 | -P1W | 10 | STUDYX | RS | 2324-P0001 | 10 | HAMD110 | HAMD1-Anxiety Psychic | HAMD 17 | No difficulty. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 11 | STUDYX | RS | 2324-P0001 | 11 | HAMD111 | HAMD1-Anxiety Somatic | HAMD 17 | Moderate. | 2 | 2 |
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| Y | 1 | 2019-11-16 | -P1W | 12 | STUDYX | RS | 2324-P0001 | 12 | HAMD112 | HAMD1-Somatic Symptoms Gastrointestinal | HAMD 17 | None. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 13 | STUDYX | RS | 2324-P0001 | 13 | HAMD113 | HAMD1-General Somatic Symptoms | HAMD 17 | None. | 0 | 0 |
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| Y | 1 | 2019-11-16 | -P1W | 14 | STUDYX | RS | 2324-P0001 | 14 | HAMD114 | HAMD1-Genital Symptoms | HAMD 17 | Mild. | 1 | 1 |
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| Y | 1 | 2019-11-16 | -P1W | 15 | STUDYX | RS | 2324-P0001 | 15 | HAMD115 | HAMD1-Hypochondriasis | HAMD 17 | Not present. | 0 | 0 |
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| 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 | 2 |
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| Y | 1 | 2019-11-16 | -P1W | 17 | STUDYX | RS | 2324-P0001 | 17 | HAMD116B | HAMD1-Loss of WT According to WK Meas | HAMD 17 |
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| 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 | 2 |
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| Y | 1 | 2019-11-16 | -P1W | 19 | STUDYX | RS | 2324-P0001 | 19 | HAMD118 | HAMD1-Total Score | HAMD 17 | 161316 | 13 | 1613 |
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| Y | 1 | 2019-11-16 | -P1W | 20 | STUDYX | RS | 2324-P0001 | 20 | HAMD101 | HAMD1-Depressed Mood | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 21 | STUDYX | RS | 2324-P0001 | 21 | HAMD102 | HAMD1-Feelings of Guilt | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 22 | STUDYX | RS | 2324-P0001 | 22 | HAMD103 | HAMD1-Suicide | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 23 | STUDYX | RS | 2324-P0001 | 23 | HAMD104 | HAMD1-Insomnia Early - Early Night | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 24 | STUDYX | RS | 2324-P0001 | 24 | HAMD105 | HAMD1-Insomnia Middle - Middle Night | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 25 | STUDYX | RS | 2324-P0001 | 25 | HAMD106 | HAMD1-Insomnia Early Hours -Morning | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 26 | STUDYX | RS | 2324-P0001 | 26 | HAMD107 | HAMD1-Work and Activities | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 27 | STUDYX | RS | 2324-P0001 | 27 | HAMD108 | HAMD1-Retardation | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 28 | STUDYX | RS | 2324-P0001 | 28 | HAMD109 | HAMD1-Agitation | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 29 | STUDYX | RS | 2324-P0001 | 29 | HAMD110 | HAMD1-Anxiety Psychic | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 30 | STUDYX | RS | 2324-P0001 | 30 | HAMD111 | HAMD1-Anxiety Somatic | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 31 | STUDYX | RS | 2324-P0001 | 31 | HAMD112 | HAMD1-Somatic Symptoms Gastrointestinal | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 32 | STUDYX | RS | 2324-P0001 | 32 | HAMD113 | HAMD1-General Somatic Symptoms | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 33 | STUDYX | RS | 2324-P0001 | 33 | HAMD114 | HAMD1-Genital Symptoms | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 34 | STUDYX | RS | 2324-P0001 | 34 | HAMD115 | HAMD1-Hypochondriasis | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 35 | STUDYX | RS | 2324-P0001 | 35 | HAMD116A | HAMD1-Loss of WT According to Patient | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 36 | STUDYX | RS | 2324-P0001 | 36 | HAMD116B | HAMD1-Loss of WT According to WK Meas | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 37 | STUDYX | RS | 2324-P0001 | 37 | HAMD117 | HAMD1-Insight | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W | 38 | STUDYX | RS | 2324-P0001 | 38 | HAMD118 | HAMD1-Total Score | HAMD 17 |
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| NOT DONE |
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| 2 | 2019-11-23 | -P1W |
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