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Table 1 Data sources and time points used to evaluate the measurement properties of the WFIRS-P

From: Psychometric validation of the Weiss Functional Impairment Rating Scale-Parent Report Form in children and adolescents with attention-deficit/hyperactivity disorder

  Lisdexamfetamine dimesylate studies Guanfacine hydrochloride extended-release studies
  SPD489-317 SPD489-325 SPD489-326 SPD503-314 SPD503-312 SDP503-316 SPD503-315
(Total N= 2357) 267 336 234 314 340 338 528
Study description Phase III, double-blind, randomized, active-controlled, parallel-group Phase III, double-blind, placebo-controlled, randomized withdrawal Phase III, randomized, double-blind, parallel-group, placebo- and active-controlled dose optimization Phase III double blind, randomized, placebo-controlled, dose optimization Phase III, double-blind, randomized, placebo-controlled, dose optimization Phase III, randomized, double-blind, parallel-group, placebo and active reference, dose optimization Phase III, double-blind, placebo-controlled, randomized withdrawal
Study Location Europe, North America, Australia Europe and U.S. Europe North America U.S. Europe, North America Europe, North America
Inclusion Criteria Historical or current inadequate response to MPH therapy; Informed consent; Willing to comply with all testing; Age 6–17; Meet DSM-IV-TR criteria for diagnosis of ADHD;Baseline ADHD-RS-IV total score ≥28; Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; able to swallow capsule Informed consent; Willing to comply with all testing; Age 6–17; Meet DSM-IV-TR criteria for diagnosis of ADHD; Baseline ADHD-RS-IV total score ≥28; Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; able to swallow capsule Informed consent; Willing to comply with all testing; Age 6–17; Completed minimum of 4 weeks of double-blind treatment without experiencing AEs; Satisfactory medical assessment; Blood pressure within 95th percentile for age, gender and height Informed consent; Willing to comply with all testing; Age 6–12; Meet DSM-IV-TR criteria for diagnosis of ADHD, combined sub-type or hyperactive/impulsive sub-type; Minimum ADHD-RS-IV total score of 28; CGI-S score of ≥4 at baseline; Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; Able to swallow capsule Informed consent; Willing to comply with all testing; Age 13–17; Meet DSM-IV-TR criteria for diagnosis of ADHD, combined sub-type or hyperactive/ impulsive sub-type; Minimum ADHD-RS-IV total score of 32; CGI-S score of ≥4 at baseline; Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; Able to swallow capsule Informed consent; Willing to comply with all testing; Age 6–17; Meet DSM-IV-TR criteria for diagnosis of ADHD, combined sub-type or hyperactive/ impulsive sub-type; Minimum ADHD-RS-IV total score of 32; CGI-S score of ≥4 at baseline; Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; Able to swallow capsule Informed consent; Willing to comply with all testing; Age 6–17; Meet DSM-IV-TR criteria for diagnosis of ADHD, combined sub-type or hyperactive/impulsive sub-type; Minimum ADHD-RS-IV total score of 32; CGI-S score of ≥4 at baseline;Blood pressure within 95th percentile for age, gender and height; functioning at age appropriate level intellectually; Able to swallow capsule
Age range, years 6–17 6–17 6–17 6–12 13–17 6–17 6–17
Baseline Baseline (Day 0) Baseline (Day 0) Baseline (Day 0) Visit 2 (baseline) Visit 2 (Day 0) All ages: Visit 2 (Day 0) Visit 2 (Day 0)
Follow-up Visit 9/ET (Day 63) Visit 7/ET (Day 49) Visit 6 (Day 56) Visit 10 (Day 56) Visit 9 (Week 7) Ages 6–12: Visit 12 (Week 7) Visit 13 (Week 13)
Ages 13–17: Visit 9 (Week 7)
  1. ADHD-RS-IV ADHD Rating Scale Version IV, CGI–SClinical Global Impression–Severity, DSM-IV-TR Statistical Manual of Mental Disorders version IV text revision, ETend of treatment, WFIRS-P Weiss Functional Impairment Rating Scale-Parent Report Form