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

(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)