ADHDPhase 4NCT00585910
Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
A Phase 4 study testing Atomoxetine and OROS Methylphenidate in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine and OROS Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2007
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female outpatients from 6 to 17 years old.
- Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
- Subject with DSM-IV diagnosis of ADHD without previous treatment.
- Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
- In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
- In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
- In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of > minor impairment OR ADHD RS >18; AND GAF score <65) will have Concerta added to their regimen.
- Subjects' parents must provide informed consent and subjects' assent.
Who cannot join
- Pregnant or nursing females or females not using proper contraception.
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
- Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
- Subjects with Mental Retardation or Organic Brain Syndromes.
- Subjects who have a lifetime history of a psychotic or bipolar disorder.
- Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
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- Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
- Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
- Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
- Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
- Subjects with a history of a lack of response to either ATMX or methylphenidate.
- Subjects with a history of a serious adverse event to either ATMX or methylphenidate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine and OROS Methylphenidate
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Strattera, Concerta, Atomoxetine, OROS Methylphenidate
- 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.
Atomoxetine and OROS MethylphenidateDrug
Also called Strattera, Concerta
Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Total treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study. Receives: Drug: Atomoxetine and OROS Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).
Measured: 7 weeks
Secondary outcomes (1)
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionDec 2007
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 ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Timothy Wilens, MD, Massachusetts General Hospital
- Investigators
- Timothy Wilens, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585910
- Sponsor's protocol ID
- 2003-P-002180
- Status last verified
- Nov 2012
- First submitted
- 21 Dec 2007
- Last updated
- 14 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00585910
- Acronym / sponsor ID
- 2003-P-002180
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Strattera, Concerta, Atomoxetine, OROS Methylphenidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 10 May 2010
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 is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atomoxetine and OROS MethylphenidateTotal treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female outpatients from 6 to 17 years old.
- Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
- Subject with DSM-IV diagnosis of ADHD without previous treatment.
- Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
- In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
Key exclusion criteria (12 listed)
- Pregnant or nursing females or females not using proper contraception.
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
- Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
- Subjects with Mental Retardation or Organic Brain Syndromes.
- Subjects who have a lifetime history of a psychotic or bipolar disorder.
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 |
|---|---|---|
| Atomoxetine and OROS MethylphenidateAlso: Strattera, ConcertaSubjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg. | Drug | 1 |
Primary outcome
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
Time frame: 7 weeks
The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).
1 secondary outcome
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- 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.
Timothy Wilens, MD principal investigator
Massachusetts General Hospital
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 Atomoxetine and OROS Methylphenidate in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital 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 8 inclusion and 12 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 14 Nov 2012. 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 10 May 2010). 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?
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS) (time frame: 7 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 14 Nov 2012.