Trial · NCT06871488
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RCT phase: Guardian rated Affective reactivity Index (ARI) | 7 days on med and for 7 days on placebo for 14 days of data collection | Thus study examines response markers for CNS stimulants to improve irritability and to improve aggression. For this second treatment phase comprised of the within subjects crossover of optimal med vs placebo, the primary outcome for irritability is the drug placebo difference in the guardian rated Affective Reactivity Index collected for 7 days over the blinded within subjects crossover phase. ARI has 6 items rated 0-2 for range of - to 14 with higher scores representing greater irritability levels. drug placebo difference on this measure will be correlated with drug placebo difference for RewP, P3b and switch positivity ERP |
| Primary | Open label dose opt: ADHD RS 5 clinician interview | 6 visits (over a max duration of 12 weeks) | For the first treatment phase (open label dose optimization) the primary outcome is the change in ADHD symptoms as measured by clinician interview using the ADHD RS 5. it has 18 items rates 0-3 with more symptoms reflecting higher scores. will measure change over time with drug; |
| Primary | RCT phase abridged Revised modified overt aggression scale (RMOAS) | 7 days on med and 7 days on placebo for 14 days of data collection | The primary rating for aggression is the drug placebo difference in the guardian rated abridged (6 reduced to 6 items) Retrospective Modified Overt Aggression Scale (RMOAS) collected for 7 days over the blinded within subjects crossover phase. The RMOAS abridged version has 6 items rated 0-3 with higher scores equating to greater levels of aggression ; drug placebo difference on this measure will be correlated with drug placebo difference for RewP, P3b and switch positivity ERP |
| Secondary | Open label dose opt: affective reactivity index -guardians (ARI) | every visit (every 1-2 weeks over max of 12 weeks) | completed every visit in open label dose opt phase by guardians. range is 0-12 with higher scores meaning more irritability; will examine change over time with med |
| Secondary | Open label dose opt: affective reactivity index teachers (ARI) | every visit (every 1-2 weeks over max of 12 weeks) | completed every visit in open label dose opt phase by teachers. range is 0-12 with higher scores representing more irritability; will examine change over time with med |
| Secondary | Open label dose opt: RMOAS by guardians | every visit (every 1-2 weeks over max of 12 weeks) | completed at every visit in this phase by guardians ; 12 items with first 4 items having 3 item likert and next 12 having 14 item likert; weighted score 0-20 for first 4 items measuring verbal incidents, 0-120 for next 4 items measuring incidents towards others and 0 to 60 for final set of 4 items measuring incidents to property for total range of 0 to 200 with higher scores meaning more aggressive behaviors; will examine change over time with med |
| Secondary | Open label dose opt: RMOAS by teachers | every visit (every 1-2 weeks over max of 12 weeks) | completed at every visit in this phase by teachers; 12 items with first 4 items having 3 item likert and next 12 having 14 item likert; weighted score 0-20 for first 4 items measuring verbal incidents, 0-120 for next 4 items measuring incidents towards others and 0 to 60 for final set of 4 items measuring incidents to property for total range of 0 to 200 with higher scores meaning more aggressive behaviors; will examine change over time with med |
| Secondary | Columbia Suicide Severity Rating Scale (CSSRS) | every visit (every 1-2 weeks over max of 12 weeks) | completed at every visit in open label dose opt and randomized crossover phase; each item is answered yes/no and scored individually |
| Secondary | RCT phase: Clinical Global Impressions: Impairment and Severity (CGI I/S) | weekly for 2 weeks | completed at every visit in each of two weeks; 1 item each for impairment and severity on 1 to 7 likert; higher numbers mean more seveirty and less improvement; will examine drug placebo difference |
| Secondary | Open label dose opt Clinical Global Impressions: Impairment and Severity (CGI I/S) | every visit (every 1-2 weeks over max of 12 weeks) | completed at every visit ; 1 item each for impairment and severity on 1 to 7 likert; higher numbers mean more severity and less improvement; will examine change over time with med |
| Secondary | Open label dose opt: Teacher Rated Inattention/Overactivity with Aggression (IOWA) | every visit (every 1-2 weeks over max of 12 weeks) | completed every visit in this phase to measure change in ADHD symptoms at school; 10 items rated 0-4 with range from 0 to 40 and higher scores = more symptoms; will examine change over time with med |
| Secondary | Open label dose opt: Guardian Rated Impairment Rated Scale (IRS) | every visit (every 1-2 weeks over max of 12 weeks) | completed at every visit; 7 items covering 7 different domains; rated 0-6 with higher scores = more impairment; no total score; will examine change over time with med |
| Secondary | Open label dose opt: Pittsburgh Side Effect Rating Scale (PSERS) | every visit (every 1-2 weeks over max of 12 weeks) | completed by guardians at every visit; 11 items rated 0-4 (range 0-44) with greater side effect severity = higher scores; will examine change over time with med |
| Secondary | Open label dose opt affective reactivity index clinician interview (CARI) | baseline (visit 1) and endpoint of this phase (max of 6 visits); each visit is spaced 1-2 weeks part so max time between measures would be 12 weeks | completed by clinician interview of guardian and child to create a consensus rating for each item; covers 11 domains of irritability with total score 0 to 100 and higher scores representing more problems; will examine change over time with med |
| Secondary | rct phase: affective reactivity index clinician interview (CARI) | completed weekly for two weeks | completed by clinician interview of guardian ; covers 11 domains of irritability with total score 0 to 100 and higher scores representing more problems; will examine mean drug placebo difference |
| Secondary | Open label dose opt: Disruptive Behavior Disorder Rating Scale (DBDRS) guardians | baseline (visit 1) and endpoint of this phase (max of 6 visits); each visit is spaced 1-2 weeks part so max time between measures would be 12 weeks | completed by guardians at first and last visit to measure change in oppositional behaviors and other conduct problems; 45 items rated 0-3 with higher scores=more symptoms (range 0-135); will examine change over time with med |
| Secondary | Open label dose opt: Disruptive Behavior Disorder Rating Scale (DBDRS) teachers | baseline (visit 1) and endpoint of this phase (max of 6 visits); each visit is spaced 1-2 weeks part so max time between measures would be 12 weeks | completed by teachers at first and last visit to measure change in oppositional behaviors and other conduct problems; 45 items rated 0-3 with higher scores=more symptoms (range 0-135); will examine change over time with med |
| Secondary | Open label dose opt: teacher rated impairment rating scale (IRS) | baseline (visit 1) and endpoint of this phase (max of 6 visits); each visit is spaced 1-2 weeks part so max time between measures would be 12 weeks | measures student functioning at school; 7 items covering 7 different domains; rated 0-6 with higher scores = more impairment; no total score; will examine change over time with med |
| Secondary | RCT Phase: Inattention/Overactivity with Aggression 5 item abridged EMA survey (IOWA) | 7 days on med and for 7 days on placebo for 14 days of data collection | given by EMA to guardians daily for the 14 days of this phase; 5 items rated 0-4 with higher scores = worse symptoms (range 0-20); will examine drug placebo difference |
| Secondary | RCT phase: Retrospective modified overt aggression scale (RMOAS) guardians | weekly for two weeks | full version of RMOAS completed once per week by guardians; 12 items with first 4 items having 3 item likert and next 12 having 14 item likert; weighted score 0-20 for first 4 items measuring verbal incidents, 0-120 for next 4 items measuring incidents towards others and 0 to 60 for final set of 4 items measuring incidents to property for total range of 0 to 200 with higher scores meaning more aggressive behaviors; will examine drug placebo difference |
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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