Long-Duration Stimulant Treatment Study of ADHD in Young Children

NCT00257725 | Completed Phase 4 Results

• 1 other identifier: 4939
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Attention-deficit/hyperactivity disorder (ADHD)

Outcome Measures

Primary Outcomes (3)

• Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)

  The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset. Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.

  week 5

• Clinical Global Impressions-Severity (CGI-S)

  CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients. Range: 0-7, higher score means worse outcome. Change from baseline is reported.

  week 5

• Children's Global Assessment Scale (C-GAS)

  Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.

  week 5

Study Arms (1)

ADHD Treatment Group

EXPERIMENTAL

Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.

Drug: B-MPH

Interventions

B-MPH DRUG

Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days

Also known as: Ritalin LA

ADHD Treatment Group

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
• Boys and girls from 4-5 years old (inclusive) at screening.
• Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
• Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
• Children with IQ of at least 70 confirmed by valid IQ test.
• Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly.
• Parents and children who can attend weekly study visits.
• Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful

You may not qualify if:

• Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
• Children taking excluded medications.
• Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
• Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
• Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
• Children with screening abnormalities deemed clinically significant by child psychiatrist.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Insitute

New York, New York, 10032, United States

Location

Related Publications (1)

• Maayan L, Paykina N, Fried J, Strauss T, Gugga SS, Greenhill L. The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate. J Child Adolesc Psychopharmacol. 2009 Apr;19(2):147-53. doi: 10.1089/cap.2008.053.

  PMID: 19374023 RESULT

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

Limitations and Caveats

The conclusions of this study are limited by its small size, the open-label design, and the possible confound of the parent training intervention.

Results Point of Contact

• Title: Laurence Greenhill, MD
• Organization: New York State Psychiatric Institute

GREENHIL@nyspi.columbia.edu

212-543-5340

Study Officials

• Laurence L Greenhill, MD

  New York State Psychiatric Insitute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist 2

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: March 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Locations

US (1)