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Trial · NCT01127607

Registered outcomes27

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

ListOutcomeTime frameDescription
SecondaryResting Blood Pressurestudy endpoint- end of period II (between subjects trial)Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).
SecondaryAlabama Parenting Questionnaire (APQ)study endpoint- end of period II (between subjects trial)
measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 ("never") to 5 ("always"). Items summed into composite scales. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).
SecondaryImpairment Rating Scale (IRS)study endpoint- end of period II (between subjects trial)
self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.
SecondaryWeightstudy endpoint- end of period II (between subjects trial)
Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).
SecondaryResting Pulsestudy endpoint- end of period II (between subjects trial)
measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).
SecondaryPittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or Moreend of medication optimization phase/week 4
Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).
SecondaryAdult ADHD Rating Scale Completed at the End of the Med Optimization Phasebaseline and end of med optimization phase/week 4
Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.

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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