C-CASA and C-SSRS in CNS Clinical Trials

Suicide Scales in Depression

Antidepressant Treatment History Form - ATHF

Used to assist clinicians in defining the adequacy and response to previous antidepressant treatments:
Standardized across study comparison
Rank information about antidepressant treatment adequacy
Time frame:

1. Both current and past episodes captured
2. 2 months euthymia required to count as separate episodes
3. Adequate medication trial at >4weeks
4. Medication start and stop dates must be obtained
5. ECT start and stop dates must be obtained

Include all medical records

Detailed as possible

1. start and stop dates
2. reason for changes
3. daily doses
4. clinical outcome of medication 

Include all psychotropic medications taken to putatively treat the condition:

Consider Antidepressant Resistance Rating (ARR) (3 or higher is adequate)

Subtract one if patient discontinued due to poor tolerability, noncompliance

ECT is not counted as a combination

Sheehan Irritability Scale - SIS

Sheehan Irritability Scale - SIS

Patient reported outcome measure measuring 7 items:

1. Irritability
2. Frustration
3. Edginess/Impatience/Overreaction
4. Moodiness
5. Anger with self
6. Anger with others
7. Temper

Subjective Global Impression - Cognition

Subjective Global Impression - Cognition

Three cognition assessments:

1. Memory
2. Attention
3. Speed of thinking

Patient reported scale

Sheehan disability Scale - SDS

Sheehan disability Scale
Self rated scale, on a continuum of 0 to 10 (not at all to Extremely)
Rates:

1. Work School 
2. Social Life
3. Family life/Home responsibilities

2 items ask for the number of days lost or unproductive 

1. Work includes unpaid volunteer work or training 
2.  Work is defined as any paid occupation
3. Last 2 items are numerical answers 

QUALITY OF LIFE ENJOYMENT AND SATISFACTION QUESTIONNAIRE - Q-LES-Q-SFSHORT FORM* ,

QUALITY OF LIFE ENJOYMENT AND SATISFACTION QUESTIONNAIRE - SHORT FORM*

Q-LES-Q-SF

This questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. 

Measures 5 domains, on a 0-5 rating scale:

1. Physical health
2. Subjective feelings
3. Leisure time Activities
4. Social Relationships
5. General Activities

 Higher scores indicate better health related quality of life

Self reported scale - that assesses the degree of enjoyment and satisfaction that the patient experienced in the past week.

If a subject has indicated that an item is poor or very poor or fair on the items with an asterisked - ask the subject to underline which factor is associated the the lack of satisfaction

QIDS-SR - Quick Inventory of Depressive Symptomatology (Self-Report)

Patient rated, 16 item severity scale.
Rates the 9 criterion domains of major depression from the DSM-IV

1. Sleep disturbance
2. Psychomotor disturbance
3. Appetite/weight disturbance
4. Depressed Mood
5. Decreased interest
6. Decreased energy
7. Worthlessness / Guilt
8. Concentration /Decision making
9. Suicidal ideation

Items rated 0 to 3, takes between 5 to 7 minutes to complete

Total score 27

1. For domains (questions relating to the same area) like sleep - use the single highest score for the domain

Remind the subject (patient) to read all questions and all possible answers - and limit responses that best describes the patient over the last period since assessment

Must complete in one sitting