Trial Outcomes & Findings for Long-Duration Stimulant Treatment Study of ADHD in Young Children (NCT NCT00257725)

Last Updated: 2020-08-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

week 5

Results posted on

2020-08-26

Participant Flow

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

The study included screening and one-week washout (if needed). All participants were entered into the study without incident.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	3

Baseline Characteristics

Long-Duration Stimulant Treatment Study of ADHD in Young Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD n=11 Participants 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.
Age, Categorical <=18 years	11 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	5.1 years STANDARD_DEVIATION .71 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: week 5

Population: Intent to treat (ITT)

Outcome measures

Outcome measures
Measure	ADHD Treatment Group n=11 Participants 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
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)	-1.09 score on a scale Standard Deviation 0.73

PRIMARY outcome

Timeframe: week 5

Population: intent to treat (ITT)

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.

Outcome measures

Outcome measures
Measure	ADHD Treatment Group n=11 Participants 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
Clinical Global Impressions-Severity (CGI-S)	-1.64 score on a scale Standard Deviation 1.29

PRIMARY outcome

Timeframe: week 5

Population: intent to treat (ITT)

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.

Outcome measures

Outcome measures
Measure	ADHD Treatment Group n=11 Participants 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
Children's Global Assessment Scale (C-GAS)	10.55 score on a scale Standard Deviation 7.70

Adverse Events

Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single-arm Open-label B-MPH Treatment in Preschoolers w ADHD n=11 participants at risk 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.
Metabolism and nutrition disorders Decreased Appetite	63.6% 7/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Gastrointestinal disorders Gastrointestinal Pain	18.2% 2/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Psychiatric disorders Emotional Lability	18.2% 2/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Nervous system disorders Trouble Sleeping	27.3% 3/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Nervous system disorders Sedation	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Gastrointestinal disorders Vomiting	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Nervous system disorders Increased Sensitivity	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Nervous system disorders Eye Twitching	100.0% 1/1 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
Nervous system disorders Headache	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
General disorders Fever	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
General disorders Virus with fever and headache	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
General disorders Nasal Congestion	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"
General disorders Eye Redness	9.1% 1/11 • 5 weeks (Baseline and 4 treatment visits) Using open-ended questions, the child psychiatrist elicited information about adverse events at baseline and at each subsequent visit. Information was obtained by observation and direct questioning such as, "Have you had any (other) medical problems since your last visit?" or "Have you felt different in any way since your last visit?"

Additional Information

Laurence Greenhill, MD

New York State Psychiatric Institute

Phone: 212-543-5340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place