Hamilton Depression Rating Scale 21-Item (HAMD 21)

CDISC SDTM HAMD 21 Questionnaire Supplement (Version 1.0) 

Hamilton Depression Rating Scale 21-Item 

(HAMD 21) 

Questionnaire Supplement to the Study Data 

Tabulation Model Implementation Guide 

for Human Clinical Trials 

Prepared by 

CDISC Questionnaire Sub-team 

Notes to Readers 

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. 

Revision History 

Date Version Summary of Changes 

2013-05-29 1.0 The Hamilton Depression Rating Scale 21-Item (HAMD 21) 

© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 

May 29, 2013


1 Introduction 

This document describes the CDISC implementation of the Hamilton Depression Rating Scale 

21-Item (HAMD 21) questionnaire, a standard questionnaire that is typically used in clinical 

trials to rate the severity of depression in patients who are already diagnosed as depressed. 

The HAMD 21 questionnaire preceded the CDISC CDASH CRF standards and based on its 

public domain status, cannot be modified to CDASH standards. 

The representation of data collected for this questionnaire is based on the Study Data Tabulation 

Model Implementation Guide (SDTMIG) QS domain model, which can be found at the CDISC 

website at: (http://www.cdisc.org/sdtm). 

These specific implementation details for this questionnaire are meant to be used in conjunction 

with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at: 

(http://www.cdisc.org/content2909). 

The CDISC Intellectual Property Policy can be found on the CDISC web site at: 

(http://www.cdisc.org/bylaws-and-policies). 

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers 

This document is a supplement to the Study Data Tabulation Model Implementation Guide for 

Human Clinical Trials and is covered under Appendix F of that document, which describes 

representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of 

the SDTMIG for a complete version of this material. 

2 Copyright Status 

This instrument is in the public domain. CDISC has included the Hamilton Rating Scale 21-Item 

(HAMD 21) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST 

for each question based on the actual question text on the questionnaire. There may be many versions 

of this questionnaire in the public domain. CDISC has chosen to use this version as the data standard. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) 

standard database structure with examples, and (3) case report forms annotated with the CDISC 

SDTMIG submission values. 

Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should 

be accessed through the CDISC website. (http://www.cdisc.org/terminology) 

CDISC has developed this documentation at no cost to users of the instrument. 


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3 The QS Domain Model 


3.1 Assumptions for Questionnaire Domain Model 

All assumptions and business rules described in the SDTMIG QS domain are applicable 

to this supplement. Additional assumptions specific to the Hamilton Depression Rating 

Scale 21-Item questionnaire are listed below: 

 

 

 

 

 

HAMD-21 is a multiple choice questionnaire consisting of 21 items, the first 17 of 

which are scored. Ratings are made during a clinical interview with the subject who 

already has been diagnosed as suffering from a depressive disorder. 

For item 16, the HAMD 21 questionnaire provides two methods by which the 

investigator may choose one method to assess the weight loss. For both methods, a 

choice of “3 = Not assessed” is present but this value is not included in calculation of 

the summary score. Generally, one of the items will be assessed (score of 0, 1, or 2) 

and the other will not be assessed (score of 3). 

The time period of evaluation for the HAMD 21 is populated in the QSEVLINT field in 

ISO 8601 format when the evaluation interval can be precisely described as duration. 

Typically, the evaluation interval for HAMD 21 is the past week. 

The questionnaire evaluator should be stored in QSEVAL. For HAMD 21, the 

evaluator is usually defined as INVESTIGATOR. 

Terminology: 

a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. 

b. A full list of value sets for qualifier, timing, result and unit fields is provided in 

Section 4: SDTM Mapping Strategy. 


May 29, 2013


3.2 Example for Hamilton Depression Rating Scale 21-Item (HAMD 21) QS Domain Model 

The HAMD 21 example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one 

subject collected at one visit for the HAMD 21 questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and 

QSCAT. The expected QS field QSBLFL is not included in this example based on its NULL value at VISITNUM=3. 

Rows 1-24: Represent the questions from the HAMD 21 form. All original results are represented with preferred terminology in QSORRES. This 

result is then transformed into a standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC. 

The evaluation interval for HAMD 21 is the past week, which is stored in QSEVLINT in ISO format. 

Row 16 & 17: Illustrates method A for the loss of weight item was assessed and method B was not assessed. For HAMD216B, this standardized 

value of 3 is not included in the calculation of the summary score. 

Row 24: Represents the summary score which can either be entered or may be derived via the detailed questions comprising the summary score. 

When derived, QSDRVFL is set to “Y”. In this example for the HAMD 21, only the first 17 question are included in the calculation of the 

summary score. 

QS.XPT 

Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN 

1 STUDYX QS P0001 1 HAMD201 HAMD2-Depressed Mood HAMD 21 These feeling states indicated only on 

questioning 

2 STUDYX QS P0001 2 HAMD202 HAMD2-Feelings of Guilt HAMD 21 Present illness is a punishment. 

Delusions of guilt 

1 1 

3 3 

3 STUDYX QS P0001 3 HAMD203 HAMD2-Suicide HAMD 21 Absent 0 0 

4 STUDYX QS P0001 4 HAMD204 HAMD2-Insomnia Early HAMD 21 No difficulty falling asleep 0 0 

5 STUDYX QS P0001 5 HAMD205 HAMD2-Insomnia Middle HAMD 21 Patient complains of being restless and 

disturbed during the night 

6 STUDYX QS P0001 6 HAMD206 HAMD2-Insomnia Late HAMD 21 Unable to fall asleep again if he gets out 

of bed 

1 1 

2 2 

7 STUDYX QS P0001 7 HAMD207 HAMD2-Work and Activities HAMD 21 No difficulty 0 0 

8 STUDYX QS P0001 8 HAMD208 HAMD2-Retardation HAMD 21 Normal speech and thought 0 0 

9 STUDYX QS P0001 9 HAMD209 HAMD2-Agitation HAMD 21 Playing with hands, hair, etc. 2 2 

10 STUDYX QS P0001 10 HAMD210 HAMD2-Anxiety Psychological HAMD 21 Subjective tension and irritability 1 1 

11 STUDYX QS P0001 11 HAMD211 HAMD2-Anxiety Somatic HAMD 21 Severe 3 3 


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12 STUDYX QS P0001 12 HAMD212 HAMD2-Somatic Symptoms Gastro-intestinal HAMD 21 None 0 0 

13 STUDYX QS P0001 13 HAMD213 HAMD2-Somatic Symptoms General HAMD 21 None 0 0 

14 STUDYX QS P0001 14 HAMD214 HAMD2-Genital Symptoms HAMD 21 Mild 1 1 

15 STUDYX QS P0001 15 HAMD215 HAMD2-Hypochondriasis HAMD 21 Frequent complaints, requests for help, 3 3 

etc. 

16 STUDYX QS P0001 16 HAMD216A HAMD2-Loss of Weight by History HAMD 21 No weight loss 0 0 

17 STUDYX QS P0001 17 HAMD216B HAMD2-Loss of Weight Measured HAMD 21 Not assessed 3 3 

18 STUDYX QS P0001 18 HAMD217 HAMD2-Insight HAMD 21 Denies being ill at all 2 2 

19 STUDYX QS P0001 19 HAMD218A HAMD2-Diurnal Variation HAMD 21 Worse in P.M. 2 2 

20 STUDYX QS P0001 20 HAMD218B HAMD2-Diurnal Variation Severity HAMD 21 Mild 1 1 

21 STUDYX QS P0001 21 HAMD219 HAMD2-Depersonalization/Derealization HAMD 21 Absent 0 0 

22 STUDYX QS P0001 22 HAMD220 HAMD2-Paranoid Symptoms HAMD 21 Suspicious 1 1 

23 STUDYX QS P0001 23 HAMD221 HAMD2-Obsessional/Compulsive Symptoms HAMD 21 Mild 1 1 

24 STUDYX QS P0001 24 HAMD222 HAMD2-Total Score HAMD 21 19 19 19 

Row QSDRVFL QSEVAL VISITNUM QSDTC QSEVLINT 

1 (cont) INVESTIGATOR 3 2012-11-16 -P1W 

















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21 (cont) INVESTIGATOR 3 2012-11-16 -P1W 



24 (cont) Y INVESTIGATOR 3 2012-11-16 -P1W 


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4 SDTM Mapping Strategy 

HAMD 21 specific mapping strategy: This section is used for reference with the annotated CRF 

for further details on the CRF data capture and to understand the alignment of the questionnaire 

to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, 

QSSTRESC, and QSSTRESN) should be populated for the questionnaire. 

QSTESTCD=HAMD201 QSTEST=HAMD2-Depressed Mood 

QSORRES QSSTRESC QSSTRESN 

Absent 0 0 

These feeling states indicated only on questioning 1 1 

These feeling states spontaneously reported verbally 2 2 

Communicates feeling states non-verbally - i.e., through 

3 3 

facial expression, posture, voice and tendency to weep 

Patient reports VIRTUALLY ONLY these feeling states in 

his spontaneous verbal and non-verbal communication 

4 4 

QSTESTCD=HAMD202 QSTEST=HAMD2-Feelings of Guilt 


Absent 0 0 

Self reproach, feels he has let people down 1 1 

Ideas of guilt or rumination over past errors or sinful deeds 2 2 

Present illness is a punishment. Delusions of guilt 3 3 

Hears accusatory or denunciatory voices and/or 

experiences threatening visual hallucinations 

4 4 

QSTESTCD=HAMD203 QSTEST=HAMD2-Suicide 


Absent 0 0 

Feels life is not worth living 1 1 

Wishes he were dead or any thoughts of possible death to 

2 2 

self 

Suicidal ideas or gesture 3 3 

Attempts at suicide (any serious attempt rates 4) 4 4 

QSTESTCD=HAMD204 QSTEST=HAMD2-Insomnia Early 


No difficulty falling asleep 0 0 

Complains of occasional difficulty falling asleep - i.e., 

1 1 

more than 1/2 hour 

Complains of nightly difficulty falling asleep 2 2 

QSTESTCD=HAMD205 QSTEST=HAMD2-Insomnia Middle 


No difficulty 0 0 

Patient complains of being restless and disturbed during 

the night 

1 1 


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Waking during the night – any getting out of bed rates 2 

(except for purposes of voiding) 

2 2 

QSTESTCD=HAMD206 QSTEST=HAMD2-Insomnia Late 



Waking in early hours of the morning but goes back to 

1 1 

sleep 

Unable to fall asleep again if he gets out of bed 2 2 

QSTESTCD=HAMD207 QSTEST=HAMD2-Work and Activities 



Thoughts and feelings of incapacity, fatigue or weakness 

1 1 

related to activities; work or hobbies 

Loss of interest in activity; hobbies or work – either 

2 2 

directly reported by patient or indirect in listlessness, 

indecision and vacillation (feels he has to push self to 

work or activities) 

Decrease in actual time spent in activities or decrease in 

3 3 

productivity 

Stopped working because of present illness 4 4 

QSTESTCD=HAMD208 QSTEST=HAMD2-Retardation 


Normal speech and thought 0 0 

Slight retardation at interview 1 1 

Obvious retardation at interview 2 2 

Interview difficult 3 3 

Complete stupor 4 4 

QSTESTCD=HAMD209 QSTEST=HAMD2-Agitation 


None 0 0 

Fidgetiness 1 1 

Playing with hands, hair, etc. 2 2 

Moving about, can’t sit still 3 3 

Hand wringing, nail biting, hair-pulling, biting of lips 4 4 

QSTESTCD=HAMD210 QSTEST=HAMD2-Anxiety Psychological 



Subjective tension and irritability 1 1 

Worrying about minor matters 2 2 

Apprehensive attitude apparent in face or speech 3 3 

Fears expressed without questioning 4 4 

QSTESTCD=HAMD211 QSTEST=HAMD2-Anxiety Somatic 



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Absent 0 0 

Mild 1 1 

Moderate 2 2 

Severe 3 3 

Incapacitating 4 4 

QSTESTCD=HAMD212 QSTEST=HAMD2-Somatic Symptoms Gastro-intestinal 


None 0 0 

Loss of appetite but eating without staff encouragement. 

1 1 

Heavy feelings in abdomen 

Difficulty eating without staff urging. Requests or requires 

laxatives or medications for bowels or medication for G.I. 

symptoms 

2 2 

QSTESTCD=HAMD213 QSTEST=HAMD2-Somatic Symptoms General 


None 0 0 

Heaviness in limbs, back or head. Backaches, headaches, 

1 1 

muscle aches. Loss of energy and fatigability 

Any clear-cut symptom rates 2 2 2 

QSTESTCD=HAMD214 QSTEST=HAMD2-Genital Symptoms 


Absent 0 0 

Mild 1 1 

Severe 2 2 

QSTESTCD=HAMD215 QSTEST=HAMD2-Hypochondriasis 


Not present 0 0 

Self-absorption (bodily) 1 1 

Preoccupation with health 2 2 

Frequent complaints, requests for help, etc. 3 3 

Hypochondriacal delusions 4 4 

QSTESTCD=HAMD216A QSTEST=HAMD2-Loss of Weight by History 


No weight loss 0 0 

Probable weight loss associated with present illness 1 1 

Definite (according to patient) weight loss 2 2 

Not assessed 3 3 

QSTESTCD=HAMD216B QSTEST=HAMD2-Loss of Weight Measured 


Less than 1 lb weight loss in week 0 0 

Greater than 1 lb weight loss in week 1 1 

Greater than 2 lb weight loss in week 2 2 

Not assessed 3 3 


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QSTESTCD=HAMD217 QSTEST=HAMD2-Insight 


Acknowledges being depressed and ill 0 0 

Acknowledges illness but attributes cause to bad food, 

1 1 

climate, overwork, virus, need for rest, etc. 

Denies being ill at all 2 2 

QSTESTCD=HAMD218A QSTEST=HAMD2-Diurnal Variation 


No variation 0 0 

Worse in A.M. 1 1 

Worse in P.M. 2 2 

QSTESTCD=HAMD218B QSTEST=HAMD2-Diurnal Variation Severity 


None 0 0 

Mild 1 1 

Severe 2 2 

QSTESTCD=HAMD219 QSTEST=HAMD2-Depersonalization/Derealization 


Absent 0 0 

Mild 1 1 

Moderate 2 2 

Severe 3 3 

Incapacitating 4 4 

QSTESTCD=HAMD220 QSTEST=HAMD2-Paranoid Symptoms 


None 0 0 

Suspicious 1 1 

Ideas of reference 2 2 

Delusions of reference and persecution 3 3 

QSTESTCD=HAMD221 QSTEST=HAMD2-Obsessional/Compulsive Symptoms 


Absent 0 0 

Mild 1 1 

Severe 2 2 

End of Document 


May 29, 2013

Hamilton Depression Rating Scale 21-Item (HAMD 21)

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