Long-Duration Stimulant Treatment Study of ADHD in Young Children

NCT ID: NCT00257725

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-03-31

Brief Summary

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

Detailed Description

This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.

Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADHD Treatment Group

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.

Group Type: EXPERIMENTAL

B-MPH

Intervention Type: DRUG

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

Interventions

B-MPH

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

Intervention Type: DRUG

Other Intervention Names

Ritalin LA

Eligibility Criteria

Inclusion Criteria

1. Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.

2. Boys and girls from 4-5 years old (inclusive) at screening.

3. 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.

4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.

5. Children with IQ of at least 70 confirmed by valid IQ test.

6. 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.

7. Parents and children who can attend weekly study visits.

8. 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

Exclusion Criteria

1. 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.

2. Children taking excluded medications.

3. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.

4. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.

5. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.

6. Children with screening abnormalities deemed clinically significant by child psychiatrist.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Laurence Greenhill

Research Psychiatrist 2

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurence L Greenhill, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Insitute

Locations

New York State Psychiatric Insitute

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19374023 (View on PubMed)

Other Identifiers

4939

Identifier Type: -

Identifier Source: org_study_id