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Updated: Nov 1, 2025

Event Related Potentials ERPs and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder ADHD
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Event Related Potentials ERPs and other EEG Based Methods for Extracting Biomarkers of Brain Dysfunction: Examples from Pediatric Attention Deficit/Hyperactivity Disorder ADHD

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Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With

Ann C Childress1,2, Andrew J Cutler3, Michelle D Po4

  • 1Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada.

The Journal of Clinical Psychiatry
|June 24, 2021
PubMed

Insights

Delayed-release and extended-release methylphenidate (DR/ER-MPH) effectively managed attention-deficit/hyperactivity disorder (ADHD) symptoms and functional impairment. Dose optimization led to significant improvements, with most children achieving response and remission thresholds.

Area of Science:

  • Pharmacology and Psychiatry
  • Pediatric Neurodevelopmental Disorders

Background:

  • Attention-deficit/hyperactivity disorder (ADHD) significantly impacts children's daily functioning.
  • Delayed-release and extended-release methylphenidate (DR/ER-MPH) is a novel stimulant formulation designed for colonic absorption.
  • Previous trials indicated DR/ER-MPH improves ADHD symptoms from morning to evening.

Purpose of the Study:

  • To explore the clinical significance of DR/ER-MPH by examining response and remission thresholds.
  • To assess the impact of dose optimization on ADHD symptom control and functional impairment.
  • To evaluate the safety profile of DR/ER-MPH in relation to starting dose.

Main Methods:

  • Post hoc analysis of data from the open-label, treatment-optimization phase of a phase 3 study (NCT02493777).
  • Participants: Children aged 6-12 years diagnosed with ADHD (DSM-5 criteria).
  • Outcome measures: ADHD Rating Scale-IV (ADHD-RS-IV), Before School Functioning Questionnaire (BSFQ), Parent Rating of Evening and Morning Behavior (PREMB-R AM/PM), Clinical Global Impressions-Improvement (CGI-I).

Main Results:

  • Mean DR/ER-MPH dose increased from 29.7 mg/d to 66.2 mg/d by week 6.
  • At week 6, high rates of response and remission were observed across all measures (e.g., ADHD-RS-IV: 97%/89%; BSFQ: 98%/94%).
  • Higher starting doses (40 mg vs. 20 mg) led to earlier achievement of thresholds (week 1, P < .02), with similar adverse event rates.

Conclusions:

  • Dose optimization of DR/ER-MPH enables sustained, all-day control of ADHD symptoms and functional impairment.
  • The majority of pediatric ADHD patients achieved response and remission thresholds, indicating functional equivalence to non-ADHD peers.
  • DR/ER-MPH demonstrates a favorable safety profile, with comparable adverse event rates across different starting doses.

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