Trial Outcomes & Findings for Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention (NCT NCT03279952)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2025-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Medication Arm CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication Arm n=11 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Age, Continuous	8 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study. However, data for this outcome was missing for one patient, so the outcome was analyzed for eight patients.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=8 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent Rated Irritability on the IOWA Connor Irritability Score From Baseline to 6 Weeks.	3.13 score on a scale Standard Deviation 2.53

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study. However, data for this outcome was missing for one patient, so the outcome was analyzed for eight patients.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=8 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent-rated ADHD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.	4.38 score on a scale Standard Deviation 2.14

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study. However, data for this outcome was missing for one patient, so the outcome was analyzed for eight patients.

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

Outcome measures

Outcome measures
Measure	Medication Arm n=8 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent-rated ODD Symptoms, as Measured by the IOWA Conners Score, From Baseline to 6 Weeks.	3.88 score on a scale Standard Deviation 4.12

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study. However, data for this variable was missing for one patient, so the outcome was analyzed for eight patients.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=8 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent-rated Impairment, as Measured by the Impairment Rating Scale (IRS), From Baseline to 6 Weeks.	14.56 score on a scale Standard Deviation 6.53

SECONDARY outcome

Timeframe: Baseline

Population: All 11 participants at baseline.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=11 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Modified Overt Aggression Scale (MOAS)	28.27 score on a scale Standard Deviation 28.78

SECONDARY outcome

Timeframe: Baseline

Population: All 11 participants at baseline.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=11 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Inventory of Callous Unemotional Traits	26 score on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study. However, data for this outcome was missing for one patient, so the outcome was analyzed for eight patients.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=8 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent-rated Affective Reactivity Index Total Score, as Measured by the Affective Reactivity Index, From Baseline to 6 Weeks.	7.6 score on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Nine patients completed the study.

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.

Outcome measures

Outcome measures
Measure	Medication Arm n=9 Participants CNS Stimulant CNS Stimulant: Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
Change in Parent-rated Side Effects, as Measured by the Pittsburgh Side Effects Rating Scale (PSERS), From Baseline to 6 Weeks	1 score on a scale Standard Deviation 3.32

Adverse Events

Medication Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raman Baweja, MD

Penn State College of Medicine

Phone: 7175318521

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place