Clinical trial scales — ADHD Practical Guide / Tris Pharma Medical Affairs

Clinical Trial Scales Scales used in clinical trials of ADHD Scales used in clinical trials of ADHD

The rating scales commonly used in clinical trials are used to measure the efficacy of interventions. Some specific functions of ADHD clinical trial rating scales include:

Determine if a patient meets the DSM criteria for a diagnosis of ADHD (See Epidemiology Section)

Assess current symptoms of ADHD

Evaluate response to treatment for ADHD

Safety scales

The rating scales commonly used in clinical trials are used to measure the efficacy of interventions. Some specific functions of ADHD clinical trial rating scales include:

Determine if a patient meets the DSM criteria for a diagnosis of ADHD (See Epidemiology Section)

Assess current symptoms of ADHD

Evaluate response to treatment for ADHD

Safety scales

Adult ADHD Clinical Diagnostic Scale (ACDS)^56,57

Available from L. Adler, MD at: adultADHD@med.nyu.edu

Age	Administration	Content	Scoring	Use
Adults	Clinician	Semi-structured interview First part is a retrospective assessment of childhood ADHD symptoms Second part is a prompted, adult-specific assessment of the 18 ADHD symptoms that have been present in the past 6 months	Subjective	Diagnosis Symptom assessment

Age

Administration

Content

Scoring

Use

Adults

Clinician

Semi-structured interview
First part is a retrospective assessment of childhood ADHD symptoms
Second part is a prompted, adult-specific assessment of the 18 ADHD symptoms that have been present in the past 6 months

Subjective

Diagnosis
Symptom assessment

ADHD Rating Scale-5 (ADHD-RS-5)^46,48

Age	Administration	Content	Scoring	Use
6-12 years	Parent/caregivers Teachers	Home/school versions 18-item scale divided into subscales for hyperactivity/impulsivity and inattentiveness Assesses symptoms of ADHD according to DSM-5 criteria⁶² Separate scoring profiles for impairment in boys and girls	4-point frequency scale 0 = never/rarely to 3 = very often Raw scores are converted to percentiles	Screening Diagnosis Treatment evaluation

Age

Administration

Content

Scoring

Use

6-12 years

Parent/caregivers
Teachers

Home/school versions
18-item scale divided into subscales for hyperactivity/impulsivity and inattentiveness
Assesses symptoms of ADHD according to DSM-5 criteria⁶²
Separate scoring profiles for impairment in boys and girls

4-point frequency scale
0 = never/rarely to 3 = very often
Raw scores are converted to percentiles

Screening
Diagnosis
Treatment evaluation

For preschoolers and adults, ADHD-RS-IV can be used (See Diagnostic Scales section)

A non-official version for adults called ADHD-RS-DSM V has been used in clinical studies⁵⁸

ADHD Investigator Symptom Rating Scale (AISRS)⁵⁹

Available from L. Adler, MD at: adultADHD@med.nyu.edu

Age	Administration	Content	Scoring	Use
Adults	Clinician	Semi-structured interview assesses each symptom domain of ADHD Captures symptoms of ADHD as they present in adulthood Suggested prompts for each item to improve interrater reliability 9 inattentive items alternate with 9 hyperactive-impulsive items Each item includes a series of additional questions that the interviewer can use to further prompt the participant	0 (none), 1 (mild), 2 (moderate), 3 (severe) The maximum total score for the scale is 54 points, with 27 points for each subscale The total score is the sum of the inattentive and hyperactive-impulsive subscales	Symptom assessment

Age

Administration

Content

Scoring

Use

Adults

Clinician

Semi-structured interview assesses each symptom domain of ADHD
Captures symptoms of ADHD as they present in adulthood
Suggested prompts for each item to improve interrater reliability
9 inattentive items alternate with 9 hyperactive-impulsive items
Each item includes a series of additional questions that the interviewer can use to further prompt the participant

0 (none), 1 (mild), 2 (moderate), 3 (severe)
The maximum total score for the scale is 54 points, with 27 points for each subscale
The total score is the sum of the inattentive and hyperactive-impulsive subscales

Symptom assessment

Clinical Global Impression (CGI) Scale (CGI-Severity [CGI-S] and CGI-Improvement [CGI-I])⁶⁰

Age	Administration	Content	Scoring	Use
Children Adults	Physician	Two companion 1-item measures assess severity of symptoms and improvement CGI-S assesses the severity of ADHD at a given point in time: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? CGI-I provides a "global" or "holistic" change in severity from the initiation of treatment (baseline) over one specified time period: Compared with the patient’s condition at admission to the project [prior to medication initiation], this patient’s condition is [score]? – Rating of "minimal improvement" (CGI-I score = 3)	CGI-S 0 = not assessed 1 = normal, not at all ill 2 = borderline mentally ill 3 = mildly ill 4 = moderately ill 5 = markedly ill 6 = severely ill 7 = among the most extremely ill patients CGI-I 1 = very much improved since the initiation of treatment 2 = much improved 3 = minimally improved 4 = no change from baseline (the initiation of treatment) 5 = minimally worse 6 = much worse	Treatment evaluation

Age

Administration

Content

Scoring

Use

Children
Adults

Physician

Two companion 1-item measures assess severity of symptoms and improvement
CGI-S assesses the severity of ADHD at a given point in time: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?
CGI-I provides a "global" or "holistic" change in severity from the initiation of treatment (baseline) over one specified time period: Compared with the patient’s condition at admission to the project [prior to medication initiation], this patient’s condition is [score]?
– Rating of "minimal improvement" (CGI-I score = 3)

CGI-S

0 = not assessed
1 = normal, not at all ill
2 = borderline mentally ill
3 = mildly ill
4 = moderately ill
5 = markedly ill
6 = severely ill
7 = among the most extremely ill patients

CGI-I

1 = very much improved since the initiation of treatment
2 = much improved
3 = minimally improved
4 = no change from baseline (the initiation of treatment)
5 = minimally worse
6 = much worse

Treatment evaluation

Brief, easy to use, and captures clinical impressions when administered by an experienced clinician.

Conners’ Global Index

Age	Administration	Content	Scoring	Use
6-18 years	Parent/caregivers Teachers Self-report	10 items designed to evaluate the frequency and severity (as observed over the preceding week) of the child’s impulsivity, emotional outbursts, and motor hyperactivity	Age- and gender-specific Scores >65 are in the clinical range for ADHD	Screening Diagnosis Treatment evaluation

Age

Administration

Content

Scoring

Use

6-18 years

Parent/caregivers
Teachers
Self-report

10 items designed to evaluate the frequency and severity (as observed over the preceding week) of the child’s impulsivity, emotional outbursts, and motor hyperactivity

Age- and gender-specific
Scores >65 are in the clinical range for ADHD

Screening
Diagnosis
Treatment evaluation

Conners’ Global Index Parent form⁷⁵

Conners’ Global Index Teacher form⁷⁶

Permanent Product Measure of Performance (PERMP-A and PERMP-C)⁶³

Age	Administration	Content	Scoring	Use
Preschool and school-aged children Adult version (Adult workplace environment PERMP1)	Teachers Clinicians Investigator	To assess compliance and academic productivity in school children (children/ adolescents) or workplace environment (adults) Assesses the time course of medication effect over the course of a day 10-minute timed test in which the number of problems attempted and number of problems correct are recorded Math test that measures effortful performance in preschool and school-aged children Series of 10-minute, skill-adjusted math tests comprising five pages of 80 math problems each (400 in total) to investigate impairments seen in the home and academic setting as a result of ADHD Administered in classroom setting (laboratory classroom)	Determines the number of problems attempted and the number of problems correctly answered Total PERMP score for each test is calculated by adding the number of math problems attempted (PERMP-A) plus the number answered correctly (PERMP-C) A higher PERMP score indicates better performance Tailored to a child’s math ability level	Screening/ placement test Treatment evaluation

Age

Administration

Content

Scoring

Use

Preschool and school-aged children
Adult version (Adult workplace environment PERMP1)

Teachers
Clinicians
Investigator

To assess compliance and academic productivity in school children (children/ adolescents) or workplace environment (adults)
Assesses the time course of medication effect over the course of a day
10-minute timed test in which the number of problems attempted and number of problems correct are recorded
Math test that measures effortful performance in preschool and school-aged children
Series of 10-minute, skill-adjusted math tests comprising five pages of 80 math problems each (400 in total) to investigate impairments seen in the home and academic setting as a result of ADHD
Administered in classroom setting (laboratory classroom)

Determines the number of problems attempted and the number of problems correctly answered
Total PERMP score for each test is calculated by adding the number of math problems attempted (PERMP-A) plus the number answered correctly (PERMP-C)
A higher PERMP score indicates better performance
Tailored to a child’s math ability level

Screening/ placement test
Treatment evaluation

Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)⁶⁴

Age	Administration	Content
School-aged children and adults	Teachers Other raters	Assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom
Level of impairment on a scale of 0 to 6 0 = none 1 = slight 2 = mild 3 = moderate 4 = severe 5 = very severe 6 = maximal impairment	Used to assess the time course of treatment effects in laboratory classroom studies or adult workplace environment

Age

Administration

Content

School-aged children and adults

Teachers
Other raters

Assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom

Scoring

Use

Level of impairment on a scale of 0 to 6

0 = none
1 = slight
2 = mild
3 = moderate
4 = severe
5 = very severe
6 = maximal impairment

Used to assess the time course of treatment effects in laboratory classroom studies or adult workplace environment

Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)^65,66

Available by contacting: Fred W. Reimherr, MD, Mood Disorders Clinic, Department of Psychiatry, University of Utah Health Science Center, Salt Lake City, UT 84132.

Age	Administration	Content
Adults	Investigator Self	61 questions in 7 symptom categories: Attention difficulties Hyperactivity/restlessness Temper Affective lability Emotional overreactivity Disorganization Impulsivity
Scoring scale is 0 to 2 0 = not present 1 = mild 2 = clearly present Summarizes each of the 7 categories on a 0-to-4 scale 0 = none 1 = mild 2 = moderate 3 = quite a bit 4 = very much	Measures severity of target symptoms of adults with ADHD using the Utah Criteria, which Wender developed

Age

Administration

Content

Adults

Investigator
Self

61 questions in 7 symptom categories:

Attention difficulties
Hyperactivity/restlessness
Temper
Affective lability
Emotional overreactivity
Disorganization
Impulsivity

Scoring

Use

Scoring scale is 0 to 2

0 = not present
1 = mild
2 = clearly present

Summarizes each of the 7 categories on a 0-to-4 scale

0 = none
1 = mild
2 = moderate
3 = quite a bit
4 = very much

Measures severity of target symptoms of adults with ADHD using the Utah Criteria, which Wender developed

Subset of 25 questions associated with ADHD

As a child I was (or had)
3	concentration problems easily distracted
4	anxious worrying
5	nervous fidgety
6	inattentive daydreaming
7	hot- or short-tempered low boiling point
9	temper outbursts tantrums
10	trouble with stick-to-it-tiveness not following through. failing to finish things started
11	stubborn strong-willed
12	sad or blue depressed unhappy
15	disobedient with parents rebellious sassy
16	low opinion of myself
17	irritable
20	moody ups and downs
21	angry
24	acting without thinking impulsive
25	tendency to be immature
26	guilty feelings regretful
27	losing control of myself
28	tendency to be or act irrational
29	unpopular with other children didn't keep friends for long didn't get along with other children
40	trouble seeing things from someone else's point of view
41	trouble with authorities trouble with school visits to principal's office
As a child in school I was (or had)
51	overall a poor student slow learner
56	trouble with mathematics or numbers
59	not achieving up to potential

May be particularly useful in assessing mood lability symptoms of ADHD.

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Scales used in clinical trials

Safety scales

Attention Deficit Hyperactivity Disorder:
A Practical Guide

Clinical Trial Scales Scales used in clinical trials of ADHD Scales used in clinical trials of ADHD

The rating scales commonly used in clinical trials are used to measure the efficacy of interventions. Some specific functions of ADHD clinical trial rating scales include:

The rating scales commonly used in clinical trials are used to measure the efficacy of interventions. Some specific functions of ADHD clinical trial rating scales include: