Attention Deficit Hyperactivity DisorderPhase 4NCT00754208
Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
A Phase 4 study testing methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Nebraska at 1 site in United States.
Trial summary
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2008to 1 Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent obtained from the legal guardian.
- Parent and child must be English-speaking.
- The child must have been living with the parent or guardian for a minimum of 6 months at the time of study entry.
- Age: 4-5 years of age at study entry.
- weight of at least 15kg (20th percentile for 4 year olds) for boys and weight of at least 14.5kg (20th percentile for 4 year olds) for girls
- Severity: age and sex-adjusted T score greater or equal to 65 on the Hyperactive- Impulsive Subscale of both the Conners Parent and Teacher Rating Scales (L)
Show all 13Show fewer
- Diagnosis: meets DSM-IV criteria for ADHD (hyperactive/impulsive or combined subtype), on Parent Diagnostic Interview Schedule for Children-IV (DISC-IV) and clinical interview by experienced clinician. ADHD must be the primary disorder.
- Duration: symptoms must have been present for a minimum of nine months.
- Impairment: less than or equal to 55 on the Child Global Assessment Scale.
- Cognitive functioning: An estimated IQ 70 or greater on the Peabody Picture Vocabulary Test (PPVT).
- School: participation in school-type program at least 2 half-days per week where class includes at least 8 peers; if child has been expelled from an eligible program in the 3 months before screening, they can be considered for enrollment as this may reflect severity of the disorder
- Parents and patients must be able to attend regular study visits.
- Children being treated with other stimulant or non-stimulant medications prior to enrollment will be allowed to discontinue treatment with these medications in order to enter the study, providing the parent wants to do so to enable their child to have a trial of Ritalin LA, the target symptoms are not well-controlled or unwanted side effects are persisting on their current treatment, and the prescribing physician is notified by the parent. These children will have a visit 1A in order to accommodate a 5 half-lives washout of their pre-study medication.
Who cannot join
- Other medications: no concurrent psychotropic medications or other medications (including herbal preparations and over-the-counter medications) with significant CNS effects (e.g., antidepressants, antipsychotics, drugs affecting blood pressure or heart rate, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, or sedating antihistamines).
- General medical conditions: children with major medical conditions that would interfere with involvement in the study or the study medication will not be enrolled.
- Serious structural cardiac abnormalities: The recent joint advisory of the American Academy of Pediatrics (AAP) and the American Heart Association (AHA) recommend use of stimulant medications should generally be avoided in patients with cardiomyopathy, serious heart rhythm or structural abnormalities, or other serious cardiac problems. Any patient with such a diagnosis will not be allowed in this study.
- Systolic and diastolic blood pressure above 95th percentile for age and gender
- Exclusionary Psychiatric Conditions: Current Adjustment Disorder, Autism, Psychosis, Bipolar Disorder, PTSD, significant suicidality, or any other psychiatric disorder in addition to ADHD that requires treatment with additional medications.
- History of physical, sexual, or emotional abuse that results in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of ADHD.
- Prior failure to respond to an adequate trial of any methylphenidate product. This will be at the determination of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Long Acting Stimulant Treatment of ADHD in Young Children
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children.
Hypotheses
- Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
- Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.
Read the detailed description
This protocol involves an 8-week, open-label, pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in 4 and 5 year old children. The purpose of this study is to ascertain pilot data on the use of long-acting stimulants in preschool-age children since virtually no data exist on these medications in this population. The interventions include utilizing short-acting methylphenidate for the initial dosing and titration and then converting the children to Ritalin LA once an optimal dose has been found. Parents will also be receiving parent education training throughout the study. Evaluations will include obtaining the ADHD-IV at every visit, side effects of the medication, vital signs, EKG, physical exam, the Clinical Global Assessment Scale, and the Clinical Global Impression-Improvement and Severity Scales. This study will also assess parent stress with the Parent Stress Index and the emotional index of the children with the Expressed Emotion Scale for Children. Follow-up will be weekly during the first month and bi-weekly during the second month.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- methylphenidate
- Keywords
- Attention Deficit Hyperactivity Disorder, Stimulant Treatment, Young Children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called Ritalin, Methylin, Ritalin LA
Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| methylpehnidate | Other | open-label treatment with methylphenidate Receives: Drug: methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.
Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity.
Measured: 8 weeks
Secondary outcomes (3)
Change in Clinical Global Impression-Severity
Change in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint. The greater the reduction in score the more improvement has been observed.
Measured: 8 weeks
Change in Children's Global Assessment Scale (CGAS) Score
This measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point. The greater the change score, the more improvement has been observed.
Measured: 8 weeks
Clinical Global Impression- Improvement
The Clinical Global Impression-Improvement scale is a measure of the clinician's assessment of the overall degree of improvement in ADHD symptoms from baseline to endpoint. The CGI-I is rated on a 1 to 6 scale, with 1=very much improved, 2=much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6=much worse. Low numerical score on this scale indicates greater improvement.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study start18 Sep 2008
- Primary completion1 Jan 2010
- Study completion1 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Daughton, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754208
- Sponsor's protocol ID
- 0380-08-FB
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2008
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Acting Stimulant Treatment of ADHD in Young Children
- ClinicalTrials.gov ID
- NCT00754208
- Acronym / sponsor ID
- 0380-08-FB
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Stimulant Treatment, Young Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 18 Sep 2008 (actual)
- Primary completion
- 1 Jan 2010 (actual)
- Study completion
- 1 Jan 2010 (actual)
- First posted
- 17 Sep 2008 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children.
Hypotheses
- Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
- Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.
Detailed description
This protocol involves an 8-week, open-label, pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in 4 and 5 year old children. The purpose of this study is to ascertain pilot data on the use of long-acting stimulants in preschool-age children since virtually no data exist on these medications in this population. The interventions include utilizing short-acting methylphenidate for the initial dosing and titration and then converting the children to Ritalin LA once an optimal dose has been found. Parents will also be receiving parent education training throughout the study. Evaluations will include obtaining the ADHD-IV at every visit, side effects of the medication, vital signs, EKG, physical exam, the Clinical Global Assessment Scale, and the Clinical Global Impression-Improvement and Severity Scales. This study will also assess parent stress with the Parent Stress Index and the emotional index of the children with the Expressed Emotion Scale for Children. Follow-up will be weekly during the first month and bi-weekly during the second month.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methylpehnidate | Other | Drug: methylphenidateopen-label treatment with methylphenidate |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Informed consent obtained from the legal guardian.
- Parent and child must be English-speaking.
- The child must have been living with the parent or guardian for a minimum of 6 months at the time of study entry.
- Age: 4-5 years of age at study entry.
- weight of at least 15kg (20th percentile for 4 year olds) for boys and weight of at least 14.5kg (20th percentile for 4 year olds) for girls
Key exclusion criteria (7 listed)
- Other medications: no concurrent psychotropic medications or other medications (including herbal preparations and over-the-counter medications) with significant CNS effects (e.g., antidepressants, antipsychotics, drugs affecting blood pressure or heart rate, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, or sedating antihistamines).
- General medical conditions: children with major medical conditions that would interfere with involvement in the study or the study medication will not be enrolled.
- Serious structural cardiac abnormalities: The recent joint advisory of the American Academy of Pediatrics (AAP) and the American Heart Association (AHA) recommend use of stimulant medications should generally be avoided in patients with cardiomyopathy, serious heart rhythm or structural abnormalities, or other serious cardiac problems. Any patient with such a diagnosis will not be allowed in this study.
- Systolic and diastolic blood pressure above 95th percentile for age and gender
- Exclusionary Psychiatric Conditions: Current Adjustment Disorder, Autism, Psychosis, Bipolar Disorder, PTSD, significant suicidality, or any other psychiatric disorder in addition to ADHD that requires treatment with additional medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidateAlso: Ritalin, Methylin, Ritalin LAStarting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day. | Drug | methylpehnidate |
Primary outcome
Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.
Time frame: 8 weeks
Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline. Higher scores indicate greater symptom severity.
3 secondary outcomes
Change in Clinical Global Impression-Severity
Time frame: 8 weeks
Change in Children's Global Assessment Scale (CGAS) Score
Time frame: 8 weeks
Clinical Global Impression- Improvement
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Daughton, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.