CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Sub-Domain: Cognitive
CRF: Hamilton Depression Rating Scale (HDRS)

Displaying 1 - 19 of 19
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C09372 Hamilton Depression Rating Scale (HDRS) - early morning insomnia indicator HDRSErlyMornInsmnInd Score for the participant/subject's difficulty, if any, with insomnia in the early morning hours, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's difficulty, if any, with insomnia in the early morning hours, as part of the Hamilton Depression Rating Scale (HDRS) Insomnia: early hours of the morning 0;1;2 No difficulty;Waking in early hours of the morning but goes back to sleep;Unable to fall asleep again if he/she gets out of bed Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09362 Hamilton Depression Rating Scale (HDRS) - general somatic symptoms indicator HDRSGenrlSomtcSymptmInd Score for the intensity of the participant/subject's general somatic symptoms, as part of the Hamilton Depression Rating Scale (HDRS) Score for the intensity of the participant/subject's general somatic symptoms, as part of the Hamilton Depression Rating Scale (HDRS) General somatic symptoms 0;1;2 None;Heaviness in limbs, back, or head. Backaches, headaches, muscle aches. Loss of energy and fatigability;Any clear-cut symptom rates 2 Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09373 Hamilton Depression Rating Scale (HDRS) - work activities difficulty indicator HDRSWrkActDifcltInd Score for the participant/subject's difficulty, if any, with work and activities, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's difficulty, if any, with work and activities, as part of the Hamilton Depression Rating Scale (HDRS) Work and activities 0;1;2;3;4 No difficulty;Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies;Loss of interest in activity, hobbies, or work - either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities);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;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. Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09363 Hamilton Depression Rating Scale (HDRS) - genital symptoms indicator HDRSGentlSymptmInd Score for the intensity of the participant/subject's genital symptoms such as loss of libido or menstrual disturbances, as part of the Hamilton Depression Rating Scale (HDRS) Score for the intensity of the participant/subject's genital symptoms such as loss of libido or menstrual disturbances, as part of the Hamilton Depression Rating Scale (HDRS) Genital symptoms(symptoms such as loss of libido, menstrual disturbances) 0;1;2 Absent;Mild;Severe Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09374 Hamilton Depression Rating Scale (HDRS) - retardation indicator HDRSRetrdtnInd Score for any retardation in the participant/subject's mental or physical behavior, as part of the Hamilton Depression Rating Scale (HDRS) Score for any retardation in the participant/subject's mental or physical behavior, as part of the Hamilton Depression Rating Scale (HDRS) Retardation (slowness of thought and speech, impaired ability to concentrate, decreased motor activity) 0;1;2;3;4 Normal speech and thought;Slight retardation during the interview;Obvious retardation during the interview;Interview difficult;Complete stupor Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09364 Hamilton Depression Rating Scale (HDRS) - hypochondriasis indicator HDRSHypchdssInd Score for the intensity of the participant/subject's hypochondriasis, as part of the Hamilton Depression Rating Scale (HDRS) Score for the intensity of the participant/subject's hypochondriasis, as part of the Hamilton Depression Rating Scale (HDRS) Hypochondriasis 0;1;2;3;4 Not present;Self-absorption (bodily);Preoccupation with health;Frequent complaints, requests for help, etc;Hypochondriacal delusions Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09375 Hamilton Depression Rating Scale (HDRS) - agitation indicator HDRSAgttnInd Score for the extent of agitated behaviors the participant/subject displays, as part of the Hamilton Depression Rating Scale (HDRS) Score for the extent of agitated behaviors the participant/subject displays, as part of the Hamilton Depression Rating Scale (HDRS) Agitation 0;1;2;3;4 None;Fidgetiness;Playing with hands, hair, etc;Moving about, can't sit still;Hand wringing, nail biting, hair-pulling, biting of lips Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09365 Hamilton Depression Rating Scale (HDRS) - weight loss patient indicator HDRSWgtLosPatInd Score for the amount of weight loss reported by the participant/subject, as part of the Hamilton Depression Rating Scale (HDRS) Score for the amount of weight loss reported by the participant/subject, as part of the Hamilton Depression Rating Scale (HDRS) Loss of weight according to the patient 0;1;2;3 No weight loss;Probable weight loss associated with present illness;Definite (according to patient) weight loss;Not assessed Numeric Values

Rate either HDRS Q16a or HDRSQ16b

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09376 Hamilton Depression Rating Scale (HDRS) - total score HDRSTotScore Value of the sum of all scores recorded, as part of the Hamilton Depression Rating Scale (HDRS) Value of the sum of all scores recorded, as part of the Hamilton Depression Rating Scale (HDRS) Total Score Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Free-Form Entry

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C09366 Hamilton Depression Rating Scale (HDRS) - weight loss measurement indicator HDRSWgtLosMeasrInd Score for the amount of the participant/subject's weight loss according to weekly measurements, as part of the Hamilton Depression Rating Scale (HDRS) Score for the amount of the participant/subject's weight loss according to weekly measurements, as part of the Hamilton Depression Rating Scale (HDRS) Loss of weight according to weekly measurements 0;1;2;3 Less than 1 lb weight loss in week;Greater than 1 lb weight loss in week;Greater than 2 lb weight loss in week;Not assessed Numeric Values

Rate either HDRS Q16a or HDRSQ16b

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09367 Hamilton Depression Rating Scale (HDRS) - insight indicator HDRSInsgtInd Score for the participant/subject's acknowledgement of depression and illness, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's acknowledgement of depression and illness, as part of the Hamilton Depression Rating Scale (HDRS) Insight 0;1;2 Acknowledges being depressed and ill;Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc;Denies being ill at all Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09368 Hamilton Depression Rating Scale (HDRS) - guilty mind indicator HDRSGltMndInd Score for the presence, qualities, and strength of the participant/subject's guilty feelings, if any, as part of the Hamilton Depression Rating Scale (HDRS) Score for the presence, qualities, and strength of the participant/subject's guilty feelings, if any, as part of the Hamilton Depression Rating Scale (HDRS) Feelings of guilt 0;1;2;3;4 Absent;Self reproach, feels he/she has let people down;Ideas of guilt or rumination over past errors or sinful deeds;Present illness is a punishment. Delusions of guilt;Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09358 Hamilton Depression Rating Scale (HDRS) - depressed mood indicator HDRSDeprsdMdInd Score for whether, how, and in what circumstances the participant/subject expresses feelings of depression (sadness, hopeless, helpless, worthless), as part of the Hamilton Depression Rating Scale (HDRS) Score for whether, how, and in what circumstances the participant/subject expresses feelings of depression (sadness, hopeless, helpless, worthless), as part of the Hamilton Depression Rating Scale (HDRS) Depressed mood (sadness, hopeless, helpless, worthless) 0;1;2;3;4 Absent;These feeling states indicated only on questioning;These feeling states spontaneously reported verbally;Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep;Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09369 Hamilton Depression Rating Scale (HDRS) - suicide indicator HDRSucdInd Score for the presence, qualities, and strength of the participant/subject's suicide-relevant thoughts and actions , if any, as part of the Hamilton Depression Rating Scale (HDRS) Score for the presence, qualities, and strength of the participant/subject's suicide-relevant thoughts and actions, if any, as part of the Hamilton Depression Rating Scale (HDRS) Suicide 0;1;2;3;4 Absent;Feels life is not worth living;Wishes he/she were dead or any thoughts of possible death to self;Ideas or gestures of suicide;Attempts at suicide (any serious attempt rate 4) Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09359 Hamilton Depression Rating Scale (HDRS) - anxiety psychic difficulty indicator HDRSAnxPsycDifcltInd Score for the participant/subject's degree of psychic anxiety, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's degree of psychic anxiety, as part of the Hamilton Depression Rating Scale (HDRS) Anxiety psychic 0;1;2;3;4 No difficulty;Subjective tension and irritability;Worrying about minor matters;Apprehensive attitude apparent in face or speech;Fears expressed without questioning Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09370 Hamilton Depression Rating Scale (HDRS) - early night insomnia indicator HDRSErlyNgtInsmnInd Score for the participant/subject's difficulty, if any, with early-night insomnia, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's difficulty, if any, with early-night insomnia, as part of the Hamilton Depression Rating Scale (HDRS) Insomnia: early in the night 0;1;2 No difficulty falling asleep;Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour;Complains of nightly difficulty falling asleep Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09360 Hamilton Depression Rating Scale (HDRS) - anxiety somatic indicator HDRSAnxSomtcInd Score for the participant/subject's grade of symptoms of somatic anxiety, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's grade of symptoms of somatic anxiety, as part of the Hamilton Depression Rating Scale (HDRS) Anxiety somatic (physiological concomitantsof anxiety) such as: gastro-intestinal - dry mouth, wind, indigestion, diarrhea, cramps, belching; cardio-vascular - palpitations, headaches; respiratory - hyperventilation, sighing; urinary frequency; sweating 0;1;2;3;4 Absent;Mild;Moderate;Severe;Incapacitating Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09371 Hamilton Depression Rating Scale (HDRS) - middle night insomnia indicator HDRSMddlNgtInsmnInd Score for the participant/subject's difficulty, if any, with middle-night insomnia, as part of the Hamilton Depression Rating Scale (HDRS) Score for the participant/subject's difficulty, if any, with middle-night insomnia, as part of the Hamilton Depression Rating Scale (HDRS) Insomnia: middle of the night 0;1;2 No difficulty;Complains of being restless and disturbed during the night;Waking during the night - any getting out of bed rates 2 (except for purposes of voiding) Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

C09361 Hamilton Depression Rating Scale (HDRS) - somatic symptoms indicator HDRSSomtcSymptmInd Score for the intensity of the participant/subject's somatic gastrointestinal symptoms, as part of the Hamilton Depression Rating Scale (HDRS) Score for the intensity of the participant/subject's somatic gastrointestinal symptoms, as part of the Hamilton Depression Rating Scale (HDRS) Somatic symptoms gastro-intestinal 0;1;2 None;Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen;Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastro-intestinal symptoms Numeric Values

for each item select the one "cue" which best characterizes the patient. Be sure to record the answers in the appropriate spaces (positions 0 through 4).

Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56-62 The HDRS is in the public domain. Adult Exploratory 3.00 2013-07-22 16:57:17.79 Hamilton Depression Rating Scale (HDRS) Cognitive Outcomes and End Points

Single Pre-Defined Value Selected

CSV