Attention Deficit Hyperactivity DisorderPhase 4NCT00866996
Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder
A Phase 4 study testing Methylphenidate extended-release; Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
Trial summary
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate extended-release; Atomoxetine
- How many people
- 1,323 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who met the DSM-IV criteria for a primary diagnosis of ADHD of any subtype (may have been newly diagnosed with ADHD and not on treatment)
- score of 24 or higher on the ADHD Rating Scale (ADHD-RS) at screening
- physician must have rated the patient as "Moderately ill" or worse on the CGI-S at screening
- children may have been enrolled who were not receiving adequate treatment for ADHD (based on clinical judgment in consultation with the parent)
- children must have been washed-out of their current treatment a minimum of 3 days or 5 half lives of the medication whichever was longer
- and the child and parent must have given written informed consent, and assent, where applicable.
Who cannot join
- Female child who had experienced menarche
- presence of eating or substance disorder or co-morbid psychiatric condition other than oppositional defiant disorder
- history of seizure, tic disorder, mental retardation, severe developmental disorder (i.e. severe cerebral palsy, autism) or family history of Tourette's Disorder
- required medications as excluded by the package inserts for Concerta or Strattera
- diagnosed with hyperthyroidism or glaucoma
- and known non-responders to treatments indicated for ADHD.
About this study
Official title: A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.
Read the detailed description
Methylphenidate and atomoxetine are available for the treatment of ADHD in children. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monamines into the extraneuronal space. The mechanism by which atomoxetine produces its therapeutic effect is thought to be related to selective inhibition of the presynaptic norephinephrine transporter. This was a multi-center, randomized, open-labeled, parallel design study of extended-release methylphenidate and atomoxetine in children aged 6 to 12 years with ADHD as evaluated by physicians and parents. Children were randomly assigned (2:1, respectively) to 3 weeks of treatment with extended-release methylphenidate or atomoxetine. Physicians evaluated treatment using the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made prior to beginning treatment (screening), at a telephone interview 1 week after beginning treatment, at a clinic visit 2 weeks after beginning treatment, and at the final clinic visit (3 weeks). Parents assessed treatment using the Parent Satisfaction Questionnaire (PSQ) from treatment days 2 to 13 and at the clinical visit 3 weeks after beginning treatment. The questions of interest included whether there is a difference between treatment in the improvement of behavior and the timing of such differences. Vital signs, height, and weight were also recorded as were adverse events. Study drug was to be taken orally once each day. Patients randomly assigned to extended-release methylphenidate began treatment with 18 mg/day. Patients randomly assigned to atomoxetine began treatment with 0.5 mg/kg/day. The study medication was to be titrated as considered appropriate by the patient's physician. The duration of treatment was 21 days.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate extended-release; Atomoxetine
- Keywords
- Attention deficit hyperactivity disorder, Methylphenidate, Atomoxetine, Concerta
- 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.
Methylphenidate extended-release; AtomoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.
Secondary outcomes (1)
CGI-I and each PSQ item separately were summarized by descriptive statistics and frequency distributions. Treatment effects were tested by chi-square statistics. Onset of effect was assessed by PSQ on Days 2 to 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,323 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866996
- Sponsor's protocol ID
- CR008329
- Status last verified
- Mar 2010
- First submitted
- 19 Mar 2009
- Last updated
- 24 May 2011
- Results posted
- No
Publications
Kemner JE, Starr HL, Ciccone PE, Hooper-Wood CG, Crockett RS. Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005 Sep-Oct;22(5):498-512. doi: 10.1007/BF02849870.
PubMed 16418159Starr HL, Kemner J. Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD. J Natl Med Assoc. 2005 Oct;97(10 Suppl):11S-16S.
PubMed 16350601
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Parallel Group Study Evaluating Treatment Outcomes of Concerta (Extended Release Methylphenidate) and Strattera (Atomoxetine) in Children With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00866996
- Acronym / sponsor ID
- CR008329
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention deficit hyperactivity disorder, Methylphenidate, Atomoxetine, Concerta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,323 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Study completion
- Dec 2003 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.
Detailed description
Methylphenidate and atomoxetine are available for the treatment of ADHD in children. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monamines into the extraneuronal space. The mechanism by which atomoxetine produces its therapeutic effect is thought to be related to selective inhibition of the presynaptic norephinephrine transporter. This was a multi-center, randomized, open-labeled, parallel design study of extended-release methylphenidate and atomoxetine in children aged 6 to 12 years with ADHD as evaluated by physicians and parents. Children were randomly assigned (2:1, respectively) to 3 weeks of treatment with extended-release methylphenidate or atomoxetine. Physicians evaluated treatment using the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made prior to beginning treatment (screening), at a telephone interview 1 week after beginning treatment, at a clinic visit 2 weeks after beginning treatment, and at the final clinic visit (3 weeks). Parents assessed treatment using the Parent Satisfaction Questionnaire (PSQ) from treatment days 2 to 13 and at the clinical visit 3 weeks after beginning treatment. The questions of interest included whether there is a difference between treatment in the improvement of behavior and the timing of such differences. Vital signs, height, and weight were also recorded as were adverse events. Study drug was to be taken orally once each day. Patients randomly assigned to extended-release methylphenidate began treatment with 18 mg/day. Patients randomly assigned to atomoxetine began treatment with 0.5 mg/kg/day. The study medication was to be titrated as considered appropriate by the patient's physician. The duration of treatment was 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients who met the DSM-IV criteria for a primary diagnosis of ADHD of any subtype (may have been newly diagnosed with ADHD and not on treatment)
- score of 24 or higher on the ADHD Rating Scale (ADHD-RS) at screening
- physician must have rated the patient as "Moderately ill" or worse on the CGI-S at screening
- children may have been enrolled who were not receiving adequate treatment for ADHD (based on clinical judgment in consultation with the parent)
- children must have been washed-out of their current treatment a minimum of 3 days or 5 half lives of the medication whichever was longer
Key exclusion criteria (6 listed)
- Female child who had experienced menarche
- presence of eating or substance disorder or co-morbid psychiatric condition other than oppositional defiant disorder
- history of seizure, tic disorder, mental retardation, severe developmental disorder (i.e. severe cerebral palsy, autism) or family history of Tourette's Disorder
- required medications as excluded by the package inserts for Concerta or Strattera
- diagnosed with hyperthyroidism or glaucoma
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 |
|---|---|---|
| Methylphenidate extended-release; Atomoxetine | Drug | – |
Primary outcome
Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.
1 secondary outcome
CGI-I and each PSQ item separately were summarized by descriptive statistics and frequency distributions. Treatment effects were tested by chi-square statistics. Onset of effect was assessed by PSQ on Days 2 to 13.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
- Results publication: PubMed 16418159Kemner JE, Starr HL, Ciccone PE, Hooper-Wood CG, Crockett RS. Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005 Sep-Oct;22(5):498-512. doi: 10.1007/BF02849870.
- Results publication: PubMed 16350601Starr HL, Kemner J. Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD. J Natl Med Assoc. 2005 Oct;97(10 Suppl):11S-16S.
- Community-based study comparing extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorderLink provided by the sponsor.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate extended-release; Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
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 6 inclusion and 6 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 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00866996, which also lists 2 linked publications.
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 24 May 2011.