Attention Deficit Disorder Medication Response Study

NCT01727414 | Completed Phase 4 Results DMC

• 2 other identifiers: ADDMedStudyK23MH083881
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates how children with Attention Deficit Disorder without Hyperactivity (ADD) respond to medication, and if their response is different from children who have problems with both hyperactivity and inattention. In order to do this, children ages 7-11 whose primary difficulty is with attention problems and who have never been on behavioral or psychiatric medications are being recruited. Once enrolled, children will try one week each of 3 different doses of methylphenidate, the most commonly prescribed Attention Deficit, Hyperactivity Disorder (ADHD) medication, as well as placebo. Children will be randomly assigned to one of six possible medication dose and placebo titration schedules, but the study doctor, family, and teacher will not know which dose (if any) children are receiving for a given week. Each week, behavioral and side effect ratings will be completed by both the child's parent and teacher, and the family will meet with the study doctor for a physical examination and to discuss how each week went. Some children will also have neuropsychological testing to determine how methylphenidate influences their working memory, sustained attention, and ability to inhibit (stop) inappropriate responses. All data will be analyzed to decide which medication dose the child responded to best and further recommendations for treatment will be given. Ultimately, this study aims to improve understanding of how children with ADHD-Primarily Inattentive Type respond to stimulant medications by

• determining whether these children experience a diminished response to methylphenidate compared to children with both hyperactivity and inattention
• determining whether certain genetic and environmental factors play a role in this response. Findings from this study will be used to help streamline the identification of the most effective doses of medication for children with ADHD-Primarily Inattentive Type.

Conditions

ADHD - Inattentive Type; ADHD - Combined Type

Keywords

ADHD; Inattention; Methylphenidate; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Attention Deficit Hyperactivity Disorder Total Symptom Score

  Assessed via parent and teacher Vanderbilt Attention Deficit Hyperactivity Disorder Rating Scales which were completed each the 4 weeks of the titration trial. Range: min=0, max=54 \[sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)\], higher scores indicate worse outcomes. Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from "week 1, week 2, week 3, week 4" to placebo, low dose, medium dose, and high dose week.

  End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week

Study Arms (2)

OROS-Methylphenidate and placebo for inattentive type pts

OTHER

Children with ADHD-inattentive type. Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.

Drug: OROS-Methylphenidate and placebo for inattentive type pts

OROS-Methylphenidate and placebo for combined type pts

OTHER

Children with ADHD-combined type type. Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.

Drug: OROS-Methylphenidate and placebo for combined type pts

Interventions

OROS-Methylphenidate and placebo for inattentive type pts DRUG

Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.

Also known as: concerta

OROS-Methylphenidate and placebo for inattentive type pts

OROS-Methylphenidate and placebo for combined type pts DRUG

Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.

OROS-Methylphenidate and placebo for combined type pts

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Consent: The family must provide signature of informed consent by a parent or legal guardian. Children must also assent to study participation.
• Age at Screening:7.0 years to 11.9 years, inclusive.
• Sex: Includes male and female children.
• ADHD Diagnostic Status: Meets DSM-IV criteria for ADHD, Predominantly Inattentive or Combined subtype with Clinical Global Impression-Severity rating corresponding to at least "moderately ill."
• Cognitive Functioning-Intelligence Quotient (IQ) of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children--4th Edition, or an Intelligence Quotient (IQ) of 80 or greater when administered the Full Scale Version of the Wechsler Intelligence Scale for Children-4th Edition.
• Absence of Learning Disability:On the abbreviated Wechsler Individual Achievement Test-2nd edition Reading and Math subtests, participants must score above 80. However, children may also be included if they receive a score of 75 or greater on the Word Reading and/or Math subtests, as long as this score is not a significant discrepancy from their full-scale IQ score (e.g., a difference of greater than one standard deviation or 15 points).
• School: Enrolled in a school setting rather than a home-school program.

You may not qualify if:

• Understanding Level: Participant and/or parent cannot understand or follow study instructions.
• Psychiatric Medications: Current or prior history of taking any medication for psychological or psychiatric problems.
• Behavioral Interventions: Current active participation in ADHD-related behavioral interventions or counseling.
• Organic Brain Injury: History of head trauma, neurological disorder, or other organic disorder affecting brain function.
• Cardiovascular Risk Factors: Children with a personal history or family history of cardiovascular risk factors will be excluded, or given the option of participating in the study after obtaining an EKG and a signed letter from a pediatric cardiologist verifying the safety of their participation in a trial of methylphenidate. In this case, families will be responsible for the costs of EKG and cardiologist evaluation. If for any reason a family is unable to assume the cost of the EKG and cardiologist evaluations but still wishes for their child to participate, study staff will determine on a case-by-case basis whether the study budget allows the study to offer financial assistance to the families for these evaluations.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Froehlich TE, Becker SP, Nick TG, Brinkman WB, Stein MA, Peugh J, Epstein JN. Sluggish Cognitive Tempo as a Possible Predictor of Methylphenidate Response in Children With ADHD: A Randomized Controlled Trial. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11553. doi: 10.4088/JCP.17m11553.

  PMID: 29489078 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Tanya Froehlich
• Organization: Cincinnati Children's Hospital

tanya.froehlich@cchmc.org

5136361154

Study Officials

• Tanya E. Froehlich, MS, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Every participant receives placebo and three different dose of MPH for one week each in a triple blinded fashion

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: November 16, 2012
• Study Start: June 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: May 18, 2021
• Results First Posted: July 18, 2017

Record last verified: 2021-04

Locations

US (1)