Table 2.
Three Rating Scales Used to Assess the Patient's Progress on Pitolisant
| Rating Scale | 2-mo Assessment Period | 12-mo Assessment Period |
|---|---|---|
| PHQ-9: Modified for Teens* | Score = 12 (moderate depression) | Score = 8 (mild depression) |
| SCARED-Parent† | Total score = 8 | Total score = 13 |
| Panic disorder (score = 1) | Panic disorder (score = 2) | |
| Generalized anxiety (score = 3) | Generalized anxiety (score = 6) | |
| Separation anxiety (score = 1) | Separation anxiety (score = 2) | |
| Social anxiety (score = 3) | Social anxiety (score = 3) | |
| Significant school avoidance (score = 0) | Significant school avoidance (score = 0) | |
| ABC-C‡ | Irritability (score = 15; max score = 45) | Irritability (score = 10; max score = 45) |
| Lethargy (score = 21; max score = 48) | Lethargy (score = 17; max score = 48) | |
| Stereotypy (score = 8; max score = 21) | Stereotypy (score = 10; max score = 21) | |
| Hyperactivity (score = 23; max score = 48) | Hyperactivity (score = 19; max score = 48) | |
| Inappropriate speech (score = 6; max score = 12) | Inappropriate speech (score = 6; max score = 12) |
ABC-C, Aberrant Behavior Checklist – Community; max, maximum; PHQ-9, Patient Health Questionnaire; SCARED-Parent, Screen for Child Anxiety Related
* A score of 0–4 = minimal depression, 5–9 = mild depression, 10–14 = moderate depression, 15–19 = moderately severe depression, 20–27 = severe depression. Scores < 4 may not need treatment. Scores 5–14, treatment is per the clinical judgement of the physician based on the patient's functional impairment and duration of symptoms. Scores > 15 warrant treatment using an antidepressant, psychotherapy, and/or a combination of treatment.
† A total score of ≥25 may indicate a presence of an anxiety disorder. Scores > 30 are more specific. A score of 7 for specified items may indicate panic disorder or significant somatic symptoms. A score of 9 for specified items may indicate generalized anxiety disorder. A score of 5 for specified items may indicate separation anxiety disorder. A score of 8 for specified items may indicate social anxiety disorder. A score of 3 of specified items may indicate significant school avoidance.
‡ ABC-C is a validated tool for caregivers to assess behavioral and emotional difficulties in youth with autism spectrum disorder and/or intellectual disabilities. It contains questions categorized into 5 specific symptom domains and uses a 0 to 3 Likert scale for scoring each question. Scores are evaluated based on mean change over time.