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titleInformation for Reviewers

Text Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Page properties
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

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
StatusREVISION DRAFT
Date20202024-0203-2806
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

DateVersionSummary of Changes
20202024-0203-28062.1 Draft
  • The HAMD 17 v2.0 supplement was updated to the WIKI clinical classifications 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 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 to be a sponsor's stated evaluation interval. 
  • Added assumption 4 describing how question items 16A and 16B are handled and included with the “Logically Skipped Item” “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 question item 16B.
  • All responses were updated to end in a period ("." punctuation as represented on ) 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 , 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.
  • Added assumptions 3b and 5c regarding RSTESTCD = "HAMD116A" and "HAMD116B", a response of RSORRES = "Not assessed." (RSSTRESC and RSSTRESN = 3). removed 0-3 from assumption 1.
2016-05-2016-05-232.0
  • 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 questionsitems
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

© 2020 Clinical 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Hamilton Depression Rating Scale 17-Item (HAMD 17) clinical classification.CDISC instrument.

There is no known standard does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this clinical classification is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this clinical classification are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG 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.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

This instrument is in the public domain. CDISC has included the HAMD 17 in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the clinical classification. There may be many versions of this instrument in the public domain or copyrighted. 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) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Info
titleInformation for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

Reference for the Hamilton Depression Rating Scale 17-Item (HAMD 17):

  • Hamilton M., Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967; 6(4):278-96. 

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the HAMD 17 are listed below.

The HAMD 17 is a multiple-choice clinical classification 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 1966, 1967, 1969, and 1980. The measure, which is designed for adult subjects, rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. It consists of 17 items, each rated on 3-point, 4-point, or 5-point scale. A total score between 0-53 is also captured.

  1. 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.", 3 = "Severe.", 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.

  2. The time period of evaluation for the HAMD 17 is populated in the RSEVINTX field as an evaluation interval text value, since it cannot 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. 

  3. 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 total score is considered as captured data when provided as part of Electronic Data Transfer (eDT) and is not considered as derived in the example below.

    1. 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 written on a CRF 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).

  4. Question 16 contains 2 components, Part A “Loss of weight according to the patient” and Part B “Loss of weight according to weekly measurements”. Only one of these items is answered when administering the HAMD 17 instrument. A record is created in qs.xpt for all items. The unanswered component is considered as a "logically skipped item" in the data and is represented as follows:

    1. QSSTAT = "NOT DONE".       

    2. QSREASND = "LOGICALLY SKIPPED ITEM".

    3. QSORRES, QSSTRESC, and QSSTRESN are set to null.

  5. Terminology

    1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the HAMD 17 RS Domain Model

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

Info

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The table represents the items from the HAMD 17 form.

available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. Based on the reference papers “Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976” and “The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.”, CDISC made a case for using the current CDISC created CRF for the HAMD 17 CDISC standard. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF. 

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG 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.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the HAMD 17 in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. 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) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Info
titleInformation for Reviewers

The CRF is attached at the top of the wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

References for the HAMD 17:

  • 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.

  • 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

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the HAMD 17 are listed below.

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 revised it in 1967. 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

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-755
 is also captured.

  1. The original scores include a numeric rating (0-2 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.

  2. The time period of evaluation for the HAMD 17 is populated in the RSEVLINT variable in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is determined based on the sponsor's stated evaluation interval.

  3. Records are created in rs.xpt for every instrument item

    1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.  

    2. Items with RSTESTCD = HAMD116A
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyQRSSUPP-756
      and HAMD116B have a response of RSORRES = "Not assessed." (RSSTRESC and RSSCTRESN = 3
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyADQRS-332
      ). Subject data for this response is included in the SDTM representation of the data as QSSTAT = "NOT DONE" and QSREASND = "Not assessed.".
    3. Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
  4. Some items on the HAMD 17 may be conditionally branched per the instrument instructions. 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 conditionally branched in the data and is represented as follows:

    1. QNAM = “RSCBRFL”, QLABEL = “Conditionally Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
    2. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
  5. The HAMD 17 instrument includes an overall score that is considered as captured data on the CRF and is not considered as derived in the example below. This overall score may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the refwrence articles.

    1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
    2. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
    3. For RSTESTCD = "HAMD116A" and "HAMD116B", a response of RSORRES = "Not assessed."
      Jira
      showSummaryfalse
      serverIssue Tracker (JIRA)
      serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
      keyQRSSUPP-757
      (RSSTRESC and RSSTRESN = 3) is not included in scoring for the HAMD 17.
  6. Terminology

    1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the HAMD 17 RS Domain Model

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

Info

We are unable to make the example consistently show blue in the wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The table represents the items from the HAMD 17 instrument. Note that visit 2 is represented as a missing visit.

Dataset wrap
Namers
Rowcaps
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. The reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

Dataset2
Dataset wrap
Namers
Represents question 16 Part B as a logically skipped item when the 16 Part A item is answered.
Rowcaps
Row 16:Represents question 16 Part A when the subject answered the weight loss according to the patient.
Row 17:
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  
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 GastrointestinalHAMD 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
2
16STUDYXRS2324-P0001
2
16
HAMD102
HAMD116AHAMD1-
Feelings of Guilt
HAMD 17Self reproach, feels he/she has let people down.11 
Loss of WT According to PatientHAMD 17Definite (according to patient) weight loss.22
 


Y12019-11-16-P1W
3
17STUDYXRS2324-P0001
3
17
HAMD103
HAMD116BHAMD1-
Suicide
Loss of WT According to WK MeasHAMD 17
Ideas or gestures of suicide.33  



NOT DONELOGICALLY SKIPPED ITEMY12019-11-16-P1W
4
18STUDYXRS2324-P0001
4
18
HAMD104
HAMD117HAMD1-
Insomnia Early - Early Night
InsightHAMD 17
No difficulty falling asleep
Denies being ill at all.
00 
22
 


Y12019-11-16-P1W
5
19STUDYXRS2324-P0001
5
19
HAMD105
HAMD118HAMD1-
Insomnia Middle - Middle Night
Total ScoreHAMD 17
No difficulty.
13
00 
1313
 


Y12019-11-16-P1W
6
20STUDYXRS2324-P0001
6
20
HAMD106
HAMD101HAMD1-
Insomnia Early Hours -Morning
Depressed MoodHAMD 17
No difficulty.00  Y12019-11-16-P1W



NOT DONE

2

21
7
STUDYXRS2324-P0001
7
21
HAMD107
HAMD102HAMD1-
Work and Activities8
Feelings of GuiltHAMD 17
No difficulty.00  Y12019-11-16-P1W



NOT DONE

2

22
STUDYXRS2324-P0001
8
22
HAMD108
HAMD103HAMD1-
Retardation
SuicideHAMD 17
Slight retardation during the interview.11  Y12019-11-16-P1W



NOT DONE

2

23STUDYXRS2324-P000123HAMD104HAMD1-Insomnia Early - Early NightHAMD 17


NOT DONE

2

24
9
STUDYXRS2324-P0001
9
24
HAMD109
HAMD105HAMD1-
Agitation
Insomnia Middle - Middle NightHAMD 17


NOT DONE
Fidgetiness.


2
1


25
1
STUDYX
 
RS
 
2324-P0001
Y
25
1
HAMD106
2019
HAMD1-
11-16-P1W
Insomnia Early Hours -MorningHAMD 17


NOT DONE

2

26
10
STUDYXRS2324-P0001
10
26
HAMD110
HAMD107HAMD1-
Anxiety Psychic11
Work and ActivitiesHAMD 17
No difficulty.00  Y12019-11-16-P1W



NOT DONE

2

27
STUDYXRS2324-P0001
11
27
HAMD111
HAMD108HAMD1-
Anxiety Somatic
RetardationHAMD 17
Moderate.12



NOT DONE

2
2  Y12019-11-16-P1W


28STUDYXRS2324-P0001
12
28
HAMD112
HAMD109HAMD1-
Somatic Symptoms GI
AgitationHAMD 17
None.



NOT DONE
00  Y12019-11-16-P1W


2

29
13
STUDYXRS2324-P0001
13
29
HAMD113
HAMD110HAMD1-
General Somatic Symptoms
Anxiety PsychicHAMD 17
None.



NOT DONE
00  Y12019-11-16-P1W


2

30
14
STUDYXRS2324-P0001
14
30
HAMD114
HAMD111HAMD1-
Genital Symptoms
Anxiety SomaticHAMD 17
Mild.11  Y12019-11-16-P1W



NOT DONE

2

31STUDYXRS2324-P000131HAMD112HAMD1-Somatic Symptoms GastrointestinalHAMD 17


NOT DONE

2

32
15
STUDYXRS2324-P0001
15
32
HAMD115
HAMD113HAMD1-
HypochondriasisHAMD 17Not present.00  Y12019-11-16-P1W
General Somatic SymptomsHAMD 17


NOT DONE

2

33
16
STUDYXRS2324-P0001
16
33
HAMD116A
HAMD114HAMD1-
Loss of WT According to Patient
Genital SymptomsHAMD 17
Definite (according to patient) weight loss.



NOT DONE

2
2


34
 
STUDYX
 
RS
Y
2324-P0001
12019-11-16-P1W
34HAMD115HAMD1-HypochondriasisHAMD 17


NOT DONE

2

35
17
STUDYXRS2324-P0001
17
35
HAMD116B
HAMD116AHAMD1-Loss of WT According to
WK Meas
PatientHAMD 17
  
 



NOT DONE
LOGICALLY SKIPPED ITEM18


2
Y12019-11-16-P1W


36
STUDYXRS2324-P0001
18
36
HAMD117
HAMD116BHAMD1-
Insight
Loss of WT According to WK MeasHAMD 17
Denies being ill at all.



NOT DONE

2
2  Y12019-11-16-P1W


37STUDYXRS2324-P000137HAMD117HAMD1-InsightHAMD 17


NOT DONE

2

38
19
STUDYXRS2324-P0001
19
38HAMD118HAMD1-Total ScoreHAMD 17
161616  Y12019-11-16-P1W



NOT DONE

2


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.

...

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

...

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

...

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 by the 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 = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms GIGastrointestinal"

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 medication for bowels or medication for gastro-intestinal gastrointestinal symptoms.22

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

...

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.22Not assessed.33

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

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