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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 | DRAFT |
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Date | 2021-03-1926 |
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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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2021-03-1926 | 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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Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.
Development of a Rating Scale for Primary Depressive Illness BY MAX HAMILTON, Department of Psychiatry, University of Lee, Brit. J. soc. Clin. Psychol. (1967), 6, pp. 278-296, Printed in Great Britain.Assessment Scales in Depression, Mania and Anxiety, Raymond W Lam, MD, FRCPC, Erin E. Michalak, PhD, Richard P Swinson, MD, FRCPsych, FRCPC, Copyright 2005 Taylor & Francis, an imprint of the Taylor & Francis Group.
- Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976.
The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.
- Assessment Scales in Depression, Mania and Anxiety, Raymond W Lam, MD, FRCPC, Erin E. Michalak, PhD, Richard P Swinson, MD, FRCPsych, FRCPC, Copyright 2005 Taylor & Francis, an imprint of the Taylor & Francis Group.
3 The RS Domain Model
3.1 Assumptions for the RS Domain Model
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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 it in 19661967, 19671976, 19691980, and 19802005. 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.
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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 GISymptoms 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 | 16 | 16 | 16 |
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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 GISymptoms 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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RSTESTCD = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms GIGastrointestinal"
RSORRES | RSSTRESC | RSSTRESN |
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None. | 0 | 0 |
Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen. | 1 | 1 |
Difficulty eating without staff urging. Requests or requires laxatives or medications for bowels or medication for gastro-intestinal gastrointestinal symptoms. | 2 | 2 |
RSTESTCD = "HAMD113" RSTEST = "HAMD1-General Somatic Symptoms"
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