Attention Deficit Hyperactivity DisorderPhase 4NCT01220440
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
A Phase 4 study testing Methylphenidate and Dextroamphetamine in people with Attention Deficit Hyperactivity Disorder, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial summary
The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate and Dextroamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2006to Dec 2008
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 9.0 to 14.0.
- ADHD diagnosis following assessment at a child \& adolescent outpatient clinic.
- Clarification for stimulant treatment.
Who cannot join
- Moderate or severe mental retardation.
- Psychosis.
- Proven brain damage.
- Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
- Epilepsy.
- The child has previously been prescribed stimulant medication or is being treated with such medication.
- The child commutes between parents or there are other factors that substantially reduce the possibility of obtaining reliable observations from parents (The child needs to live in one place through out the whole trial since otherwise might severely influence the child's behaviour and the observations).
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ostfold Hospital Neuropsychiatric Unit
Fredrikstad, Østfold fylke, 1605
Østfold Hospital Neuropsychiatric Unit
Fredrikstad, Østfold fylke, 1605
About this study
The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).
Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, Placebo, Dextroamphetamine
- Keywords
- ADHD, Children, Methylphenidate, Dextroamphetamine, Placebo, Crossover, Double Blind, Neuropsychological tests, Behavioural Questionnaires
- 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
Methylphenidate:10mg x 3 for one week
PlaceboDrug
Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.
DextroamphetamineDrug
Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate, Dexamphetamine, Placebo | Experimental | The 36 participants received each of the three medications for two weeks. Six different medication sequences are possible. The participants are randomly chosen for each of the six sequences in a way that allow six participants into each of the six sequences to balance the sequences. Receives: Drug: Methylphenidate; Drug: Placebo; Drug: Dextroamphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD and ODD symptoms
Parent and Teacher Questionnaire (completed monday till friday every week) Self-Report Questionnaire (completed once every week) Test Performance Questionnaire (completed by the child after each testsession)
Measured: Every week for six weeks
Change in attention, motor activity and executive functioning
QB test is a computer based continuous performance test (visual attention and motor activity).
Score!from Test of Everyday Attention - Childrens Edition (auditory attention). C. Golden version of Stroop Test(prosessing-speed and inhibitory control). Grooved Pegboard from the Hallstead battery (motor speed).
Measured: The neuropsychological tests are administered once on each type of medication during the six week trial
Change in side-effects
Side-Effects Rating Scale (R. Barkley)
Measured: Once every week through the six week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionDec 2008
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Arne K. Henriksen, Phd, Study director, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220440
- Sponsor's protocol ID
- 3208
- Status last verified
- Oct 2010
- First submitted
- 28 Sep 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
Publications
Ramtvedt BE, Aabech HS, Sundet K. Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate. J Child Adolesc Psychopharmacol. 2014 Apr;24(3):130-9. doi: 10.1089/cap.2013.0114. Epub 2014 Mar 25.
PubMed 24666268Ramtvedt BE, Roinas E, Aabech HS, Sundet KS. Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. J Child Adolesc Psychopharmacol. 2013 Nov;23(9):597-604. doi: 10.1089/cap.2012.0085. Epub 2013 May 9.
PubMed 23659360
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
- ClinicalTrials.gov ID
- NCT01220440
- Acronym / sponsor ID
- 3208
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Children, Methylphenidate, Dextroamphetamine, Placebo, Crossover, Double Blind, Neuropsychological tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Oct 2010 (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 study compares the efficacy of methylphenidate, dextroamphetamine and placebo on neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD within a double-blind cross-over design over six weeks. The assessment of ADHD followed formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A neuropsychological testbattery and four behavioral questionnaires were selected as efficacy variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory control, motor activity), Score (auditory attention), Stroop Test (processing speed, inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed by a parent and a teacher Monday till Friday through every week), Test Performance Questionnaire (completed by the child immediately after each of the three test sessions).
Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will provide better results than a trial including only Met. a)Met and Dex are efficient as treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to Met. b)At an individual level some of the participants will show positive response to one type of stimulants and no response, mixed response or adverse response to the other type of stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in agreement but also add unique information in the assessment of the effect of stimulants. d)Qb-test is sensitive and valid as a measure of the effect of stimulants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate, Dexamphetamine, Placebo | Experimental | Drug: Methylphenidate, Drug: Placebo, Drug: DextroamphetamineThe 36 participants received each of the three medications for two weeks. Six different medication sequences are possible. The participants are randomly chosen for each of the six sequences in a way that allow six participants into each of the six sequences to balance the sequences. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 9.0 to 14.0.
- ADHD diagnosis following assessment at a child \& adolescent outpatient clinic.
- Clarification for stimulant treatment.
Key exclusion criteria (7 listed)
- Moderate or severe mental retardation.
- Psychosis.
- Proven brain damage.
- Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
- Epilepsy.
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 |
|---|---|---|
| MethylphenidateMethylphenidate:10mg x 3 for one week | Drug | Methylphenidate, Dexamphetamine, Placebo |
| PlaceboPlacebo: 1 pill x 2 for one week, 2 pills x 2 for one week. | Drug | Methylphenidate, Dexamphetamine, Placebo |
| DextroamphetamineDextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week | Drug | Methylphenidate, Dexamphetamine, Placebo |
Primary outcome
Change in ADHD and ODD symptoms
Time frame: Every week for six weeks
Parent and Teacher Questionnaire (completed monday till friday every week) Self-Report Questionnaire (completed once every week) Test Performance Questionnaire (completed by the child after each testsession)
Change in attention, motor activity and executive functioning
Time frame: The neuropsychological tests are administered once on each type of medication during the six week trial
QB test is a computer based continuous performance test (visual attention and motor activity). Score!from Test of Everyday Attention - Childrens Edition (auditory attention). C. Golden version of Stroop Test(prosessing-speed and inhibitory control). Grooved Pegboard from the Hallstead battery (motor speed).
Change in side-effects
Time frame: Once every week through the six week trial
Side-Effects Rating Scale (R. Barkley)
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 14 Oct 2010.
- Derived from this study: PubMed 24666268Ramtvedt BE, Aabech HS, Sundet K. Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate. J Child Adolesc Psychopharmacol. 2014 Apr;24(3):130-9. doi: 10.1089/cap.2013.0114. Epub 2014 Mar 25.
- Derived from this study: PubMed 23659360Ramtvedt BE, Roinas E, Aabech HS, Sundet KS. Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. J Child Adolesc Psychopharmacol. 2013 Nov;23(9):597-604. doi: 10.1089/cap.2012.0085. Epub 2013 May 9.
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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.
Arne K. Henriksen, Phd study director
Ostfold Hospital Trust
2 sites 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 and Dextroamphetamine in people with Attention Deficit Hyperactivity Disorder, run by Ostfold Hospital Trust at 2 sites in Norway.
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 3 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 14 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
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?
Change in ADHD and ODD symptoms (time frame: Every week for six weeks). The study lists 3 primary outcomes in all. 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 NCT01220440, 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 14 Oct 2010.