Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Attention-deficit/hyperactivity disorder (ADHD)
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.
Interventions
DRUGB-MPH
Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) | week 5 | 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. |
| Clinical Global Impressions-Severity (CGI-S) | week 5 | 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. |
| Children's Global Assessment Scale (C-GAS) | week 5 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through the NYSPI Child and Adolescent Evaluation Service (CAPES), physician referrals, local and web advertising, and flyers. Recruitment took place between March 2005 and August 2007
Pre-assignment details
The study included screening and one-week washout (if needed). All participants were entered into the study without incident.
Participants by arm
| Arm | Count |
|---|---|
| Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 5.1 years STANDARD_DEVIATION 0.71 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 7 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
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.
Time frame: week 5
Population: intent to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADHD Treatment Group | Children's Global Assessment Scale (C-GAS) | 10.55 score on a scale | Standard Deviation 7.7 |
p-value: 0.01paired t-test
Primary
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.
Time frame: week 5
Population: intent to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADHD Treatment Group | Clinical Global Impressions-Severity (CGI-S) | -1.64 score on a scale | Standard Deviation 1.29 |
p-value: 0.01paired t-test
Primary
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.
Time frame: week 5
Population: Intent to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADHD Treatment Group | Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) | -1.09 score on a scale | Standard Deviation 0.73 |
p-value: 0.01paired t-test