ADHDPhase 4NCT03279952
Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
A Phase 4 study testing CNS Stimulant in people with ADHD, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why children get… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- CNS Stimulant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Age <5 years of age or >12 years of age.
- Children with significant visual or hearing deficits or sensitivity to loud noises as test performance requires intact hearing and vision.
- Children with a latex allergy as the sensors used in electrophysiology assessments have a latex component.
- Serious neurological conditions that impacts cognition, such as an active seizure disorder
- Current psychotropics other than FDA approved ADHD medications, as medication will be withheld on testing days. Unlike most other psychotropic medications, CNS stimulants can be withheld for brief periods and acutely restarted with no safety risks and lengthy titration process. Numerous ADHD studies have safely withdrawn these medications or substituted inert placebo for testing or clinical observation. Children taking an approved nonstimulant for ADHD plus a CNS Stimulant medication will be allowed to participate and will just have their CNS stimulant dose withheld on testing days.
- Prominent traits of autism spectrum disorder (Social Communication Questionnaire Score >15), marked developmental delay or psychiatric conditions requiring urgent treatment (mania, psychoses, suicidal ideation).
- Parent or child not fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why children get referred for treatment. It has been identified as transdiagnostic entity meriting investigation as a treatment target for personalized intervention given its prevalence and morbidity. Most children with prominent irritability also meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of children with ADHD manifest impairing levels of irritability. Irritability levels are only minimally correlated with severity of ADHD symptoms suggesting that irritability is not simply a manifestation of severe ADHD. The first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with baseline mood lability being the best marker for both improving and worsening irritability. In addition, increased irritability is one of the most common reasons why parents stop these medications. The unpredictability in response to CNS stimulants has led to the increasing use of antipsychotics and other non-evidence based treatments for ADHD. It is unknown what drives this heterogeneity in response in part because little is known about the underlying causal mechanisms for irritability in youth with ADHD. Two areas theorized to contribute to irritability include impairments in learning from experience (instrumental learning) and sensitivity to reward and loss.1 There are objective methods for measuring these domains in children through the use of even-related potentials (ERPs)- synchronous neural activity in response to a stimulus. Reward positivity (RewP) is an ERP component occurring in response to feedback on task performance that can be broken down to separate reward and loss components. Irritability is thought to arise due to the combination of an enhanced drive for reward coupled with an excessive response to loss. No prior work has examined associations of RewP with irritability in ADHD. However, abnormalities in RewP and elevated irritability have both been established as risk factors for depression, suggesting that RewP may also predict irritability. Error related negativity (ERN) reflects the preconscious detection of potential conflict serving as an early warning signal for errors. Error detection is one of the first steps for instrumental learning. It is impaired in some youth with ADHD, with a suppressed ERN correlated with reduced error processing. CNS stimulants improve ERN amplitude and impaired error processing. We theorize that abnormalities in RewP and ERN in children with ADHD will serve as respective markers for severity of irritability and subsequent treatment response to CNS stimulants. If successful, we will have identified a causal pathway for irritability that will aide treatment development and identified a reliable biomarker for the current first line treatment for irritability in ADHD (CNS Stimulants), while providing care to a significantly impaired group of local children for whom few evidence-based treatments exist.
Read the detailed description
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger.In children, irritability manifests as a persistently negative mood and frequent temper outbursts. Severe, persistent irritability has been conceptualized as Disruptive Mood Dysregulation Disorder (DMDD) with 3% of children meeting criteria for it. Most youth with DMDD have Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of patients with ADHD exhibit impairing irritability. Even in children not meeting full DMDD criteria, irritability causes a range of impairments and is a risk factor for depression, suicide and substance use. Irritability has been identified as transdiagnostic entity meriting investigation as a target for personalized intervention. Irritability levels are only minimally correlated with severity of ADHD symptoms or impairments in executive functioning, suggesting that irritability is distinct and not simply a manifestation of severe ADHD. Presently, the first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with some children experiencing complete remission of their irritability and others experience worsening irritability. Increased irritability is one of the most common reasons why parents stop these medications. It is unknown what drives this heterogeneity in response as no reliable treatment markers have been identified. The unpredictability of CNS stimulants has led to the increasing use of atypical antipsychotics for the off label treatment of ADHD. While effective, these medications are associated with concerning side effects.
In order to identify markers of treatment response, it is necessary to delineate the causal pathways underlying irritability. However, the mechanisms driving irritability are largely unknown. Two areas theorized to contribute to irritability are impairments in learning from experience (instrumental learning) and sensitivity to reward and loss. There are objective, reliable methods for measuring these domains in children through the use of event related potentials (ERPs), synchronous neural activity derived from the electroencephalogram (EEG) in response to a stimulus. Reward positivity (RewP) is an ERP occurring in response to feedback on task performance that can be broken down to separately analyze response to gain (delta frequency) and loss (theta frequency). No prior work has examined these components of RewP with irritability but others have found unique associations of each with depression. As irritability is an established risk factor for depression, it is reasonable to surmise that RewP may predict irritability as well. Error related negativity (ERN) reflects the preconscious detection of potential conflict, serving as an early warning signal for errors and a first step to adapting behavior in response to achieve a desired goal (e.g., instrumental learning.) A subset of children with ADHD exhibit a suppressed ERN on cognitive tasks, and ERN amplitude is associated with task performance. When suppressed, CNS stimulants normalize ERN, which is correlated with improved task performance. We theorize that abnormalities in RewP to reward and loss on a monetary guessing task will predict the severity of irritability, while ERN amplitude on a response inhibition task will predict the degree of improvement in irritability after dose optimization of CNS stimulants. These associations will be assessed in 47 children with ADHD and elevated levels of irritability using daily parent ratings gathered before and after optimization of CNS stimulant. To address the great variability in a child's daily behavior, we will use the recommended collection format of ecological momentary assessment (EMA) to gather multiple daily ratings of irritability. Lastly, there is a longstanding concern that CNS stimulants may lead to rebound irritability late in the day as their effects fade. It is unclear if this simply represents a return to the premedication baseline that parents perceive as more severe after observing improved behavior earlier in the day or a true worsening in irritability. Therefore, we will use EMA to compare changes in irritability during medicated times of day versus unmedicated times, theorizing that greater daytime improvement will be associated with parents rating worse evening behavior.
Aim1: Examine the capacity of lab measurements of reward sensitivity to predict irritability in ADHD children H1: After controlling for relevant covariates, gain-related delta and loss-related theta activity in the EEG during a reward-guessing task will each correlate with levels of the child's irritability.
H2:Children with elevated levels of both loss related theta \&gain-related delta will exhibit the greatest irritability.
Aim2: Examine the capacity of ERN amplitude during a response inhibition task done in the unmedicated state to predict the capacity of CNS stimulants to reduce irritability in children with ADHD.
H1: Smaller baseline ERN will predict greater improvement in irritability with optimization of stimulant dose.
Aim3: Examine the phenomena of rebound irritability with wear-off of the therapeutic effect of CNS stimulants.
H1: Greater reductions in irritability when the CNS stimulant is active will be associated with parents reporting increasing irritability after the stimulant has worn off.
- Conditions
- ADHD
- Being tested
- CNS Stimulant
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNS StimulantDrug
Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
| Study group | Role | What they receive |
|---|---|---|
| medication arm | Other | CNS Stimulant Receives: Drug: CNS Stimulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parent Rated Irritability on the IOWA Connor Irritability Score From Baseline to 6 Weeks.
The primary outcome in this study was that change in parent rated irritability on the IOWA Connor irritability score. Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scales has 3 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-9), higher score indicates more irritability.
Measured: Baseline and 6 weeks
Change in Parent-rated ADHD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.
Symptom severity for ADHD symptoms will be assessed using the IOWA Connor Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scale has 5 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-15). higher score indication of more ADHD symptoms.
Measured: Baseline and 6 weeks
Change in Parent-rated ODD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.
Oppositional Defiant Disorder (ODD) symptoms were assessed using the IOWA Connor Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scale has 5 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-15). Higher scores reflect greater levels ODD symptoms
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Change in Parent-rated Impairment, as Measured by the Impairment Rating Scale (IRS), From Baseline to 6 Weeks.
Parents completed the Impairment Rating Scale (IRS) to assess functioning across multiple domains. The IRS evaluates impairment in peer relationships, interactions with siblings and parents, academic performance, classroom behavior, self-esteem, family functioning, and overall functioning. Each item is rated on a 0-6 scale, and a total score is calculated by summing all item scores. Total scores range from 0 to 48, with higher scores indicating greater impairment.
Measured: Baseline and 6 weeks
Modified Overt Aggression Scale (MOAS)
Parents completed the Modified Overt Aggression Scale (MOAS) to measure aggression. The Modified Overt Aggression Scale (MOAS) is a structured 20-item assessment tool used to measure the frequency and severity of aggressive behaviors. It categorizes aggression into four domains: verbal aggression, aggression against property, aggression towards self-directed, and physical aggression against others. Each item is rated on a scale from 0 (no aggression) to 4 (severe aggression), and scores within each domain are weighted (Verbal = ×1, Property = ×2, Autoaggression = ×3, Physical = ×4) to calculate a total weighted score ranging from 0 to 100. Higher scores indicate greater overall aggression.
Measured: Baseline
Inventory of Callous Unemotional Traits
Parents completed Inventory of Callous Unemotional Traits to measure callous-unemotional characteristics. The Inventory of Callous-Unemotional Traits (ICU) is a 24-item scale designed to assess callous-unemotional traits in youth. Each item is rated on a 4-point scale ranging from 0 (Not at all) to 3 (Definitely true), producing a total score between 0 and 96. Higher scores reflect increased levels of callous-unemotional characteristics.
Measured: Baseline
Change in Parent-rated Affective Reactivity Index Total Score, as Measured by the Affective Reactivity Index, From Baseline to 6 Weeks.
Parents completed the Affective Reactivity Index as an additional measure of irritability. The Affective Reactivity Index (ARI) is a 7-item scale used to assess irritability in youth. Each item is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Certainly true), resulting in a total score between 0 and 14. Higher scores reflect greater levels of irritability.
Measured: Baseline and 6 weeks
Change in Parent-rated Side Effects, as Measured by the Pittsburgh Side Effects Rating Scale (PSERS), From Baseline to 6 Weeks
Parents completed the Pittsburgh Side Effects Rating Scale (PSERS) to evaluate side effects. The Pittsburgh Side Effects Rating Scale (PSERS) is a tool used to assess side effects commonly associated with medication treatment for ADHD. It includes 13 items rated on a Likert scale ranging from 0 (None) to 3 (Severe), yielding a total score from 0 to 39. Higher scores indicate more severe side effects.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jun 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: challenge in recruitment\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raman Baweja, Milton S. Hershey Medical Center
- Investigators
- Raman Baweja, MD, MS, Principal investigator, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279952
- Sponsor's protocol ID
- IRB: 00008087
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2017
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
- ClinicalTrials.gov ID
- NCT03279952
- Acronym / sponsor ID
- IRB: 00008087
- Conditions
- ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: challenge in recruitment\]
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger. Irritability worsens peer relationships, family functioning, academic performance and is a risk factor for depression, suicide and substance use and is one of the main reasons why children get referred for treatment. It has been identified as transdiagnostic entity meriting investigation as a treatment target for personalized intervention given its prevalence and morbidity. Most children with prominent irritability also meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of children with ADHD manifest impairing levels of irritability. Irritability levels are only minimally correlated with severity of ADHD symptoms suggesting that irritability is not simply a manifestation of severe ADHD. The first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with baseline mood lability being the best marker for both improving and worsening irritability. In addition, increased irritability is one of the most common reasons why parents stop these medications. The unpredictability in response to CNS stimulants has led to the increasing use of antipsychotics and other non-evidence based treatments for ADHD. It is unknown what drives this heterogeneity in response in part because little is known about the underlying causal mechanisms for irritability in youth with ADHD. Two areas theorized to contribute to irritability include impairments in learning from experience (instrumental learning) and sensitivity to reward and loss.1 There are objective methods for measuring these domains in children through the use of even-related potentials (ERPs)- synchronous neural activity in response to a stimulus. Reward positivity (RewP) is an ERP component occurring in response to feedback on task performance that can be broken down to separate reward and loss components. Irritability is thought to arise due to the combination of an enhanced drive for reward coupled with an excessive response to loss. No prior work has examined associations of RewP with irritability in ADHD. However, abnormalities in RewP and elevated irritability have both been established as risk factors for depression, suggesting that RewP may also predict irritability. Error related negativity (ERN) reflects the preconscious detection of potential conflict serving as an early warning signal for errors. Error detection is one of the first steps for instrumental learning. It is impaired in some youth with ADHD, with a suppressed ERN correlated with reduced error processing. CNS stimulants improve ERN amplitude and impaired error processing. We theorize that abnormalities in RewP and ERN in children with ADHD will serve as respective markers for severity of irritability and subsequent treatment response to CNS stimulants. If successful, we will have identified a causal pathway for irritability that will aide treatment development and identified a reliable biomarker for the current first line treatment for irritability in ADHD (CNS Stimulants), while providing care to a significantly impaired group of local children for whom few evidence-based treatments exist.
Detailed description
There has been an increasing focus on the adverse impacts of irritability, defined as increased tendency towards anger.In children, irritability manifests as a persistently negative mood and frequent temper outbursts. Severe, persistent irritability has been conceptualized as Disruptive Mood Dysregulation Disorder (DMDD) with 3% of children meeting criteria for it. Most youth with DMDD have Attention Deficit Hyperactivity Disorder (ADHD) but only a subset of patients with ADHD exhibit impairing irritability. Even in children not meeting full DMDD criteria, irritability causes a range of impairments and is a risk factor for depression, suicide and substance use. Irritability has been identified as transdiagnostic entity meriting investigation as a target for personalized intervention. Irritability levels are only minimally correlated with severity of ADHD symptoms or impairments in executive functioning, suggesting that irritability is distinct and not simply a manifestation of severe ADHD. Presently, the first line treatment for irritability in children with ADHD is to optimize the dose of the CNS stimulant. However, there is great heterogeneity in response, with some children experiencing complete remission of their irritability and others experience worsening irritability. Increased irritability is one of the most common reasons why parents stop these medications. It is unknown what drives this heterogeneity in response as no reliable treatment markers have been identified. The unpredictability of CNS stimulants has led to the increasing use of atypical antipsychotics for the off label treatment of ADHD. While effective, these medications are associated with concerning side effects.
In order to identify markers of treatment response, it is necessary to delineate the causal pathways underlying irritability. However, the mechanisms driving irritability are largely unknown. Two areas theorized to contribute to irritability are impairments in learning from experience (instrumental learning) and sensitivity to reward and loss. There are objective, reliable methods for measuring these domains in children through the use of event related potentials (ERPs), synchronous neural activity derived from the electroencephalogram (EEG) in response to a stimulus. Reward positivity (RewP) is an ERP occurring in response to feedback on task performance that can be broken down to separately analyze response to gain (delta frequency) and loss (theta frequency). No prior work has examined these components of RewP with irritability but others have found unique associations of each with depression. As irritability is an established risk factor for depression, it is reasonable to surmise that RewP may predict irritability as well. Error related negativity (ERN) reflects the preconscious detection of potential conflict, serving as an early warning signal for errors and a first step to adapting behavior in response to achieve a desired goal (e.g., instrumental learning.) A subset of children with ADHD exhibit a suppressed ERN on cognitive tasks, and ERN amplitude is associated with task performance. When suppressed, CNS stimulants normalize ERN, which is correlated with improved task performance. We theorize that abnormalities in RewP to reward and loss on a monetary guessing task will predict the severity of irritability, while ERN amplitude on a response inhibition task will predict the degree of improvement in irritability after dose optimization of CNS stimulants. These associations will be assessed in 47 children with ADHD and elevated levels of irritability using daily parent ratings gathered before and after optimization of CNS stimulant. To address the great variability in a child's daily behavior, we will use the recommended collection format of ecological momentary assessment (EMA) to gather multiple daily ratings of irritability. Lastly, there is a longstanding concern that CNS stimulants may lead to rebound irritability late in the day as their effects fade. It is unclear if this simply represents a return to the premedication baseline that parents perceive as more severe after observing improved behavior earlier in the day or a true worsening in irritability. Therefore, we will use EMA to compare changes in irritability during medicated times of day versus unmedicated times, theorizing that greater daytime improvement will be associated with parents rating worse evening behavior.
Aim1: Examine the capacity of lab measurements of reward sensitivity to predict irritability in ADHD children H1: After controlling for relevant covariates, gain-related delta and loss-related theta activity in the EEG during a reward-guessing task will each correlate with levels of the child's irritability.
H2:Children with elevated levels of both loss related theta \&gain-related delta will exhibit the greatest irritability.
Aim2: Examine the capacity of ERN amplitude during a response inhibition task done in the unmedicated state to predict the capacity of CNS stimulants to reduce irritability in children with ADHD.
H1: Smaller baseline ERN will predict greater improvement in irritability with optimization of stimulant dose.
Aim3: Examine the phenomena of rebound irritability with wear-off of the therapeutic effect of CNS stimulants.
H1: Greater reductions in irritability when the CNS stimulant is active will be associated with parents reporting increasing irritability after the stimulant has worn off.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medication arm | Other | Drug: CNS StimulantCNS Stimulant |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Age <5 years of age or >12 years of age.
- Children with significant visual or hearing deficits or sensitivity to loud noises as test performance requires intact hearing and vision.
- Children with a latex allergy as the sensors used in electrophysiology assessments have a latex component.
- Serious neurological conditions that impacts cognition, such as an active seizure disorder
- Current psychotropics other than FDA approved ADHD medications, as medication will be withheld on testing days. Unlike most other psychotropic medications, CNS stimulants can be withheld for brief periods and acutely restarted with no safety risks and lengthy titration process. Numerous ADHD studies have safely withdrawn these medications or substituted inert placebo for testing or clinical observation. Children taking an approved nonstimulant for ADHD plus a CNS Stimulant medication will be allowed to participate and will just have their CNS stimulant dose withheld on testing days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNS StimulantParticipants will be stabilized by any FDA approved CNS stimulant medication during open label trial. | Drug | medication arm |
Primary outcome
Change in Parent Rated Irritability on the IOWA Connor Irritability Score From Baseline to 6 Weeks.
Time frame: Baseline and 6 weeks
The primary outcome in this study was that change in parent rated irritability on the IOWA Connor irritability score. Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scales has 3 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-9), higher score indicates more irritability.
Change in Parent-rated ADHD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.
Time frame: Baseline and 6 weeks
Symptom severity for ADHD symptoms will be assessed using the IOWA Connor Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scale has 5 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-15). higher score indication of more ADHD symptoms.
Change in Parent-rated ODD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.
Time frame: Baseline and 6 weeks
Oppositional Defiant Disorder (ODD) symptoms were assessed using the IOWA Connor Parent Rating Scale rating symptoms on a 0-3 likert. Higher scores mean severe symptoms This scale has 5 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-15). Higher scores reflect greater levels ODD symptoms
5 secondary outcomes
Change in Parent-rated Impairment, as Measured by the Impairment Rating Scale (IRS), From Baseline to 6 Weeks.
Time frame: Baseline and 6 weeks
Modified Overt Aggression Scale (MOAS)
Time frame: Baseline
Inventory of Callous Unemotional Traits
Time frame: Baseline
Change in Parent-rated Affective Reactivity Index Total Score, as Measured by the Affective Reactivity Index, From Baseline to 6 Weeks.
Time frame: Baseline and 6 weeks
Change in Parent-rated Side Effects, as Measured by the Pittsburgh Side Effects Rating Scale (PSERS), From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raman Baweja, MD, MS principal investigator
Penn State Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CNS Stimulant in people with ADHD, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parent Rated Irritability on the IOWA Connor Irritability Score From Baseline to 6 Weeks. (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.