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Title

Hamilton Depression Rating Scale 17-Item (HAMD 17)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

HAMD 17

QRS Permission StatusPublic Domain
TeamMajor Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.1
StatusDRAFT
Date2019-12-0405
NotesThis 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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DateVersionSummary of Changes
2019-12-04052.1 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, since 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 to be a sponsor's stated evaluation interval. 
  • Added assumption 4 describing how question 16A and 16B are handled and included the “Presence of Data” items missing data rule.
  • The example replaced the RSBLFL variable with RSLOBXFL, added the RSDTC variable and uses the RSTAT and RSREASND variables for the unanswered question 16B.
  • All responses were updated to end in a "." punctuation as represented on the CRF.
2016-05-232.0
  • This measure was re-evaluated to fit the definition of a clinical classification measure.  The domain was changed from the QS to RS domain.
2013-05-151.1
  • Q16 only uses Part A or Part B and not both questions
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

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Dataset wrap
Namers


Rowcaps


Row 16:Represents question 16 Part A when the subject answered the weight loss question.
Row 17:

Represents question 16 Part B 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.



Dataset2


RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSREASNDRSLOBXFLVISITNUMRSDTCRSEVLINT
1STUDYXRS2324-P00011HAMD101HAMD1-Depressed MoodHAMD 17Absent.00  Y12019-11-16-P1W
2STUDYXRS2324-P00012HAMD102HAMD1-Feelings of GuiltHAMD 17Self reproach, feels he/she has let people down.11  Y12019-11-16-P1W
3STUDYXRS2324-P00013HAMD103HAMD1-SuicideHAMD 17Ideas or gestures of suicide.33  Y12019-11-16-P1W
4STUDYXRS2324-P00014HAMD104HAMD1-Insomnia Early - Early NightHAMD 17No difficulty falling asleep.00  Y12019-11-16-P1W
5STUDYXRS2324-P00015HAMD105HAMD1-Insomnia Middle - Middle NightHAMD 17No difficulty.00  Y12019-11-16-P1W
6STUDYXRS2324-P00016HAMD106HAMD1-Insomnia Early Hours -MorningHAMD 17No difficulty.00  Y12019-11-16-P1W
7STUDYXRS2324-P00017HAMD107HAMD1-Work and ActivitiesHAMD 17No difficulty.00  Y12019-11-16-P1W
8STUDYXRS2324-P00018HAMD108HAMD1-RetardationHAMD 17Slight retardation during the interview.11  Y12019-11-16-P1W
9STUDYXRS2324-P00019HAMD109HAMD1-AgitationHAMD 17Fidgetiness.11  Y12019-11-16-P1W
10STUDYXRS2324-P000110HAMD110HAMD1-Anxiety PsychicHAMD 17No difficulty.00  Y12019-11-16-P1W
11STUDYXRS2324-P000111HAMD111HAMD1-Anxiety SomaticHAMD 17Moderate.22  Y12019-11-16-P1W
12STUDYXRS2324-P000112HAMD112HAMD1-Somatic Symptoms GIHAMD 17None.00  Y12019-11-16-P1W
13STUDYXRS2324-P000113HAMD113HAMD1-General Somatic SymptomsHAMD 17None.00  Y12019-11-16-P1W
14STUDYXRS2324-P000114HAMD114HAMD1-Genital SymptomsHAMD 17Mild.11  Y12019-11-16-P1W
15STUDYXRS2324-P000115HAMD115HAMD1-HypochondriasisHAMD 17Not present.00  Y12019-11-16-P1W
16STUDYXRS2324-P000116HAMD116AHAMD1-Loss of WT According to PatientHAMD 17Definite (according to patient) weight loss.22  Y12019-11-16-P1W
17STUDYXRS2324-P000117HAMD116BHAMD1-Loss of WT According to WK MeasHAMD 17   NOT DONENO RESPONSE COLLECTEDY12019-11-16-P1W
18STUDYXRS2324-P000118HAMD117HAMD1-InsightHAMD 17Denies being ill at all.22  Y12019-11-16-P1W
19STUDYXRS2324-P000119HAMD118HAMD1-Total ScoreHAMD 17161616  Y12019-11-16-P1W




4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

...

RSTESTCD = "HAMD101" RSTEST = "HAMD1-Depressed Mood"

RSORRES

RSSTRESC

RSSTRESN

Absent.00
These feeling states indicated only on questioning.11
These feeling states spontaneously reported verbally.22
Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.33
Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.44

RSTESTCD = "HAMD102" RSTEST = "HAMD1-Feelings of Guilt"

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Self reproach, feels he/she has let people down.11
Ideas of guilt or rumination over past errors or sinful deeds.22
Present illness is a punishment. Delusions of guilt.33
Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.44

RSTESTCD = "HAMD103" RSTEST = "HAMD1-Suicide"

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Feels life is not worth living.11
Wishes he/she were dead or any thoughts of possible death to self.22
Ideas or gestures of suicide.33
Attempts at suicide (any serious attempt rates 4).44

RSTESTCD = "HAMD104" RSTEST = "HAMD1-Insomnia Early - Early Night"

RSORRES

RSSTRESC

RSSTRESN

No difficulty falling asleep.00
Complains of occasional difficulty falling asleep, i.e. more than ½ hour.11
Complains of nightly difficulty falling asleep.22

RSTESTCD = "HAMD105" RSTEST = "HAMD1-Insomnia Middle - Middle Night"

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Patient complains of being restless and disturbed during the night.11
Waking during the night – any getting out of bed rates 2 (except for purposes of voiding).22

RSTESTCD = "HAMD106" RSTEST = "HAMD1-Insomnia Early Hours - Morning"

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Waking in early hours of the morning but goes back to sleep.11
Unable to fall asleep again if he/she gets out of bed.22

RSTESTCD = "HAMD107" RSTEST = "HAMD1-Work and Activities"

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.11
Loss of interest in activity, hobbies or work – either directly reported by patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).22
Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.33
Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.44

RSTESTCD = "HAMD108" RSTEST = "HAMD1-Retardation"

RSORRES

RSSTRESC

RSSTRESN

Normal speech and thought.00
Slight retardation during the interview.11
Obvious retardation during the interview.22
Interview difficult.33
Complete stupor.44

RSTESTCD = "HAMD109" RSTEST = "HAMD1-Agitation"

RSORRES

RSSTRESC

RSSTRESN

None.00
Fidgetiness.11
Playing with hands, hair, etc.22
Moving about, can’t sit still.33
Hand wringing, nail biting, hair-pulling, biting of lips.44

RSTESTCD = "HAMD110" RSTEST = "HAMD1-Anxiety Psychic"

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Subjective tension and irritability.11
Worrying about minor matters.22
Apprehensive attitude apparent in face or speech.33
Fears expressed without questioning.44

RSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety Somatic"

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Mild.11
Moderate.22
Severe.33
Incapacitating.44

RSTESTCD = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms GI"

RSORRES

RSSTRESC

RSSTRESN

None.00
Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.11
Difficulty eating without staff urging. Requests or requires laxatives or medications for bowels or medication for gastro-intestinal symptoms.22

RSTESTCD = "HAMD113" RSTEST = "HAMD1-General Somatic Symptoms"

RSORRES

RSSTRESC

RSSTRESN

None.00
Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.11
Any clear-cut symptom rates 2.22

RSTESTCD = "HAMD114" RSTEST = "HAMD1-Genital Symptoms"

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Mild.11
Severe.22

RSTESTCD = "HAMD115" RSTEST = "HAMD1-Hypochondriasis"

RSORRES

RSSTRESC

RSSTRESN

Not present.00
Self-absorption (bodily).11
Preoccupation with health.22
Frequent complaints, requests for help, etc.33
Hypochondriacal delusions.44

RSTESTCD = "HAMD116A" RSTEST = "HAMD1-Loss of WT According to Patient"

RSORRES

RSSTRESC

RSSTRESN

No weight loss.00
Probable weight loss associated with present illness.11
Definite (according to patient) weight loss.22
Not assessed.33

RSTESTCD = "HAMD116B" RSTEST = "HAMD1-Loss of WT According to WK Meas"

RSORRES

RSSTRESC

RSSTRESN

Less than 1 lb weight loss in week.00
Greater than 1 lb weight loss in week.11
Greater than 2 lb weight loss in week.22
Not assessed.33

RSTESTCD = "HAMD117" RSTEST = "HAMD1-Insight"

RSORRES

RSSTRESC

RSSTRESN

Acknowledges being depressed and ill.00
Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.11
Denies being ill at all.22




End of Document