Registered outcomes17

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

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Clinical Global Impression-Severity-Severe Mood Dysregulation	Baseline through week 12.	A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.
Secondary	ADHD-IV Rating Scale	Baseline through week 12.	A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.
Secondary	Conners Parent Global Index	Baseline through week 3.	Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.
Secondary	Conners Global Index Emotional Lability Subscale - Parent Report	Baseline to week 3.	A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.
Secondary	Conners Global Index Restless-Impulsive Subscale Parent Report	Baseline through week 3.	A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.
Secondary	Conners Teacher Global Index	Baseline through week 3.	Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.
Secondary	Affective Reactivity Index - Parent Report	Baseline through week 12.	A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.
Secondary	Revised Modified Overt Aggression Scale - Total Score	Baseline through week 12.	A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.
Secondary	Clinical Global Impression - Improvement	Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.	Percentage improved by treatment group
Secondary	Height	Baseline through week 12.	A dimensional measure assessed in cms.
Secondary	Weight	Baseline through week 12.	Weight in kg.
Secondary	Pulse	Baseline through week 12.	Heart rate in beats per minute.
Secondary	Systolic Blood Pressure	Baseline through week 12.	Systolic Blood Pressure measured in mmHG
Secondary	Diastolic Blood Pressure	Baseline through week 12.	Diastolic Blood pressure measured in mmHG.
Other	Pediatric Anxiety Rating Scale	Baseline through week 12.	Clinician completed dimensional assessment of anxiety symptoms.
Other	Children's Depression Rating Scale	Baseline through week 12.	Clinician completed dimensional rating of depressive symptoms.
Other	Affective Reactivity Index Child Report	Baseline through week 12.	Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.

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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