Trial · NCT06871488
Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
NCT06871488, Phase 4, Recruiting, Milton S. Hershey Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants. Trials, record NCT06871488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06871488
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
- NCT number
- NCT06871488
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 136 participants, estimated
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- ADHD - Attention Deficit Disorder With Hyperactivity, Irritability, Aggression Childhood
- Interventions
- CNS Stimulant, Placebo, CNS Stimulant open label first phase
- First posted
- 2025-03-12
- Last updated
- 2026-04-20
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06871488
GET https://conductscience.org/api/trials/v1/NCT06871488/registered?page=2