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Trial · NCT02484703

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryPercentage of Participants With Adverse Events (AEs)Baseline up to Week 6
PrimaryPercentage of Participants With Epileptiform Abnormalities as Assessed Using Electroencephalogram (EEG) AnalysisBaseline up to Week 6
PrimaryPercentage of Participants by Suicidality Classification as Assessed Using an Adapted Form of the Columbia Classification Algorithm for Suicide Assessment (C-CASA)Baseline up to Week 6
PrimaryAnxiety, Depression, and Mood Scale (ADAMS) ScoreBaseline up to Week 6
PrimaryHyperactivity and Impulsivity as Assessed by the Short Version of Conners Third Edition Parent Short-Form (Conners-3) ScoreBaseline up to Week 6
PrimarySleep Disturbances as Assessed by the Children's Sleep Habits Questionnaire (CSHQ) ScoreBaseline up to Week 6
PrimaryGamma Power at Posterior Electrodes as Assessed Using EEG AnalysisBaseline up to Week 6
PrimaryTheta Power at Posterior Electrodes as Assessed Using EEG AnalysisBaseline up to Week 6
PrimaryCognition as Assessed by the Children's Memory Scale (CMS) Subtests ScoreBaseline up to Week 6
SecondaryPercentage of Participants With AEsBaseline up to Week 26
SecondaryPercentage of Participants With Epileptiform Abnormalities as Assessed Using EEG AnalysisBaseline up to Week 26
SecondaryPercentage of Participants by Suicidality Classification as Assessed Using an Adapted Form of the C-CASABaseline up to Week 26
SecondaryADAMS ScoreBaseline up to Week 26
SecondaryHyperactivity and Impulsivity as Assessed by the Short Version of Conners-3 ScoreBaseline up to Week 26
SecondarySleep Disturbances as Assessed by the CSHQ ScoreBaseline up to Week 26
SecondaryGamma Power at Posterior Electrodes as Assessed Using EEG AnalysisBaseline up to Week 26
SecondaryTheta Power at Posterior Electrodes as Assessed Using EEG AnalysisBaseline up to Week 26
SecondaryCognition as Assessed by the CMS Subtests ScoreBaseline up to Week 26
SecondaryAdaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) ScoreBaseline up to Week 26
SecondaryClinical Global Impression-Improvement (CGI-I) Scale ScoreBaseline up to Week 26

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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