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Trial · NCT00499863

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpointbaseline and endpoint (up to 7 weeks)
The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
SecondaryChange From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at EndpointBaseline and endpoint (up to 7 weeks)The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).
SecondaryImprovement in Clinical Global Impressions-Improvement (CGI-I) Scoreup to 7 weeks
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
SecondaryImprovement in Parent Global Assessment (PGA) Scoreup to 7 weeks
Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
SecondaryChange From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at EndpointBaseline and endpoint (up to 7 weeks)
The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).
SecondaryDermal Response Scale (DRS) Scoresup to 7 weeksMean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
SecondaryChange From Baseline in Electrocardiogram Results(QTcF Interval) at EndpointBaseline and endpoint (up to 7 weeks)
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
SecondaryChange From Baseline in Pulse Rate at EndpointBaseline and endpoint (up to 7 weeks)
SecondaryChange From Baseline in Systolic Blood Pressure at EndpointBaseline and endpoint (up to 7 weeks)
SecondaryChange From Baseline in Diastolic Blood Pressure at EndpointBaseline and endpoint (up to 7 weeks)
SecondaryChange From Baseline in Weight at EndpointBaseline and endpoint (up to 7 weeks)
OtherPost Sleep Questionnaire (PSQ) Quality of Sleepup to 7 weeksPost Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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