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Trial · NCT01714310

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYClinical Global Impression-Severity-Severe Mood DysregulationBaseline through week 12.Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYADHD-IV Rating ScaleBaseline through week 12.Participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYConners Parent Global IndexBaseline through week 3.Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYConners Global Index Emotional Lability Subscale - Parent ReportBaseline to week 3.Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYConners Global Index Restless-Impulsive Subscale Parent ReportBaseline through week 3.Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYConners Teacher Global IndexBaseline through week 3.Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYAffective Reactivity Index - Parent ReportBaseline through week 12.Some participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYRevised Modified Overt Aggression Scale - Total ScoreBaseline through week 12.Some participants discontinued as trial progressed.units on a scaleLEAST_SQUARES_MEAN
SECONDARYClinical Global Impression - ImprovementPercentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.Some participants discontinued as trial progressed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYHeightBaseline through week 12.Participants discontinued as trial progressed.cm.LEAST_SQUARES_MEAN
SECONDARYWeightBaseline through week 12.Some participants discontinued as trial progressed.kg.LEAST_SQUARES_MEAN
SECONDARYPulseBaseline through week 12.Some participants discontinued as trial progressed.beats per minute.LEAST_SQUARES_MEAN
SECONDARYSystolic Blood PressureBaseline through week 12.Some participants discontinued as trial progressed.mm Hg.LEAST_SQUARES_MEAN
SECONDARYDiastolic Blood PressureBaseline through week 12.Some participants discontinued as trial progressed.mm Hg.LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDPediatric Anxiety Rating ScaleBaseline through week 12.
OTHER_PRE_SPECIFIEDChildren's Depression Rating ScaleBaseline through week 12.
OTHER_PRE_SPECIFIEDAffective Reactivity Index Child ReportBaseline through week 12.

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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