Attention Deficit Hyperactivity DisorderPhase 2NCT02695355
ERP Based Single-dose Predictions of Stimulants
A Phase 2 study testing Methylphenidate (MPH) in people with Attention Deficit Hyperactivity Disorder, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The purpose of this study was to see if the clinical outcome of stimulant medication (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant medication. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate (MPH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2006to Sep 2015
- Phase
- Phase 2
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients referred to the clinic diagnosed with Attention Deficit Hyperactivity Disorder. Cases With comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included.
Who cannot join
- Patients With intelligence coefficients below 70 or a diagnosed neurological disease are excluded.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Pediatric Neuropsychiatric Team, Østfold Hospital Trust
Fredrikstad, 1605
About this study
Official title: Pediatric Attention Deficit Hyperactivity Disorder: Predicting Clinical Response to Stimulant Medication From Single-dose Changes in Event Related Potentials
The purpose of this study was to see if the clinical outcome of stimulant medication (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the performance of an attention task).
Read the detailed description
In the pediatric neuropsychiatric clinic of Ostfold Hospital Trust, Norway, patients diagnosed with attention deficit hyperactivity disorder are tested with quantitative EEG (QEEG) and ERPs to supplement the neuropsychological examination. In the majority of cases a systematic four weeks trial on stimulant medication is offered, and the clinical effects are evaluated at the end of the try-out period. This procedure is a clinical routine. In this study patients and parents were asked if they were willing to complete a second QEEG/ERP test on a single dose of stimulant medication shortly before the onset of the four weeks trial. They were explained that the aim of the study was to search for predictors of clinical response. They were also informed that this second test was completely voluntary. (In fact the vast majority were quite enthusiastic). The patients were characterized as responders (REs - medication continued) or non-responders (non-REs - medication stopped) based on explicit criteria. The single-dose induced changes in ERPs (and behavioral parameters from the attention test; number of errors, reaction times) were examined, and differences between REs and non-REs were calculated.
If the analysis of data show that one or several variables are significantly different in REs and non-REs with large effect sizes, these findings may eventually result in the development of a useful clinical tool.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate (MPH)
- 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 (MPH)Drug
Also called Ritalin tablets
Test 1: No medication. Registration of ERPs and behavioral data during an attention task. Test 2: Test repeated on a single dose of MPH. Outcome measure: Classification as responders or non-responders after a four weeks medication trial, based on rating scales from parents and Teachers.
| Study group | Role | What they receive |
|---|---|---|
| ADHD medication effects | Experimental | Single dose methylphenidate (Ritalin tablets); 10 mg for ages 8-13; 15 mg for ages 13-17 Receives: Drug: Methylphenidate (MPH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification as responders (REs) or non-responders (non-REs) based on daily ratings from parents and teachers of ADHD symptoms during a four weeks medication trial
Measured: Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startOct 2006
- Primary completionJan 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geir Ogrim, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695355
- Sponsor's protocol ID
- AB3330
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ogrim G, Hestad KA, Brunner JF, Kropotov J. Predicting acute side effects of stimulant medication in pediatric attention deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a continuous-performance test. Neuropsychiatr Dis Treat. 2013;9:1301-9. doi: 10.2147/NDT.S49611. Epub 2013 Sep 5.
PubMed 24043939Ogrim G, Kropotov J, Brunner JF, Candrian G, Sandvik L, Hestad KA. Predicting the clinical outcome of stimulant medication in pediatric attention-deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a go/no-go test. Neuropsychiatr Dis Treat. 2014 Feb 3;10:231-42. doi: 10.2147/NDT.S56600. eCollection 2014.
PubMed 24523588Hermens DF, Cooper NJ, Kohn M, Clarke S, Gordon E. Predicting stimulant medication response in ADHD: evidence from an integrated profile of neuropsychological, psychophysiological and clinical factors. J Integr Neurosci. 2005 Mar;4(1):107-21. doi: 10.1142/s0219635205000653.
PubMed 16041867Johnston BA, Coghill D, Matthews K, Steele JD. Predicting methylphenidate response in attention deficit hyperactivity disorder: a preliminary study. J Psychopharmacol. 2015 Jan;29(1):24-30. doi: 10.1177/0269881114548438. Epub 2014 Sep 18.
PubMed 25237119Barkley RA. Predicting the response of hyperkinetic children to stimulant drugs: a review. J Abnorm Child Psychol. 1976;4(4):327-48. doi: 10.1007/BF00922531.
PubMed 794087Chabot RJ, Orgill AA, Crawford G, Harris MJ, Serfontein G. Behavioral and electrophysiologic predictors of treatment response to stimulants in children with attention disorders. J Child Neurol. 1999 Jun;14(6):343-51. doi: 10.1177/088307389901400601.
PubMed 10385840Riccio CA, Waldrop JJ, Reynolds CR, Lowe P. Effects of stimulants on the continuous performance test (CPT): implications for CPT use and interpretation. J Neuropsychiatry Clin Neurosci. 2001 Summer;13(3):326-35. doi: 10.1176/jnp.13.3.326.
PubMed 11514638Sangal RB, Sangal JM. Attention-deficit/hyperactivity disorder: use of cognitive evoked potential (P300) to predict treatment response. Clin Neurophysiol. 2006 Sep;117(9):1996-2006. doi: 10.1016/j.clinph.2006.06.004. Epub 2006 Aug 4.
PubMed 16890481Young ES, Perros P, Price GW, Sadler T. Acute challenge ERP as a prognostic of stimulant therapy outcome in attention-deficit hyperactivity disorder. Biol Psychiatry. 1995 Jan 1;37(1):25-33. doi: 10.1016/0006-3223(94)00075-E.
PubMed 7893855Czerniak SM, Sikoglu EM, King JA, Kennedy DN, Mick E, Frazier J, Moore CM. Areas of the brain modulated by single-dose methylphenidate treatment in youth with ADHD during task-based fMRI: a systematic review. Harv Rev Psychiatry. 2013 May-Jun;21(3):151-62. doi: 10.1097/HRP.0b013e318293749e.
PubMed 23660970Linssen AM, Vuurman EF, Sambeth A, Nave S, Spooren W, Vargas G, Santarelli L, Riedel WJ. Contingent negative variation as a dopaminergic biomarker: evidence from dose-related effects of methylphenidate. Psychopharmacology (Berl). 2011 Dec;218(3):533-42. doi: 10.1007/s00213-011-2345-x. Epub 2011 May 20.
PubMed 21597989Ogrim G, Kropotov JD. Predicting Clinical Gains and Side Effects of Stimulant Medication in Pediatric Attention-Deficit/Hyperactivity Disorder by Combining Measures From qEEG and ERPs in a Cued GO/NOGO Task. Clin EEG Neurosci. 2019 Jan;50(1):34-43. doi: 10.1177/1550059418782328. Epub 2018 Jun 25.
PubMed 29940782Aasen IE, Ogrim G, Kropotov J, Brunner JF. Methylphenidate selectively modulates one sub-component of the no-go P3 in pediatric ADHD medication responders. Biol Psychol. 2018 Apr;134:30-38. doi: 10.1016/j.biopsycho.2018.02.011. Epub 2018 Feb 21.
PubMed 29476840
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Attention Deficit Hyperactivity Disorder: Predicting Clinical Response to Stimulant Medication From Single-dose Changes in Event Related Potentials
- ClinicalTrials.gov ID
- NCT02695355
- Acronym / sponsor ID
- AB3330
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Mar 2016 (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 see if the clinical outcome of stimulant medication (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the performance of an attention task).
Detailed description
In the pediatric neuropsychiatric clinic of Ostfold Hospital Trust, Norway, patients diagnosed with attention deficit hyperactivity disorder are tested with quantitative EEG (QEEG) and ERPs to supplement the neuropsychological examination. In the majority of cases a systematic four weeks trial on stimulant medication is offered, and the clinical effects are evaluated at the end of the try-out period. This procedure is a clinical routine. In this study patients and parents were asked if they were willing to complete a second QEEG/ERP test on a single dose of stimulant medication shortly before the onset of the four weeks trial. They were explained that the aim of the study was to search for predictors of clinical response. They were also informed that this second test was completely voluntary. (In fact the vast majority were quite enthusiastic). The patients were characterized as responders (REs - medication continued) or non-responders (non-REs - medication stopped) based on explicit criteria. The single-dose induced changes in ERPs (and behavioral parameters from the attention test; number of errors, reaction times) were examined, and differences between REs and non-REs were calculated.
If the analysis of data show that one or several variables are significantly different in REs and non-REs with large effect sizes, these findings may eventually result in the development of a useful clinical tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD medication effects | Experimental | Drug: Methylphenidate (MPH)Single dose methylphenidate (Ritalin tablets); 10 mg for ages 8-13; 15 mg for ages 13-17 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients referred to the clinic diagnosed with Attention Deficit Hyperactivity Disorder. Cases With comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included.
Key exclusion criteria (1 listed)
- Patients With intelligence coefficients below 70 or a diagnosed neurological disease are excluded.
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 (MPH)Also: Ritalin tabletsTest 1: No medication. Registration of ERPs and behavioral data during an attention task. Test 2: Test repeated on a single dose of MPH. Outcome measure: Classification as responders or non-responders after a four weeks medication trial, based on rating scales from parents and Teachers. | Drug | ADHD medication effects |
Primary outcome
Classification as responders (REs) or non-responders (non-REs) based on daily ratings from parents and teachers of ADHD symptoms during a four weeks medication trial
Time frame: Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.
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 1 Mar 2016.
- Results publication: PubMed 24043939Ogrim G, Hestad KA, Brunner JF, Kropotov J. Predicting acute side effects of stimulant medication in pediatric attention deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a continuous-performance test. Neuropsychiatr Dis Treat. 2013;9:1301-9. doi: 10.2147/NDT.S49611. Epub 2013 Sep 5.
- Results publication: PubMed 24523588Ogrim G, Kropotov J, Brunner JF, Candrian G, Sandvik L, Hestad KA. Predicting the clinical outcome of stimulant medication in pediatric attention-deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a go/no-go test. Neuropsychiatr Dis Treat. 2014 Feb 3;10:231-42. doi: 10.2147/NDT.S56600. eCollection 2014.
- Results publication: PubMed 16041867Hermens DF, Cooper NJ, Kohn M, Clarke S, Gordon E. Predicting stimulant medication response in ADHD: evidence from an integrated profile of neuropsychological, psychophysiological and clinical factors. J Integr Neurosci. 2005 Mar;4(1):107-21. doi: 10.1142/s0219635205000653.
- Results publication: PubMed 25237119Johnston BA, Coghill D, Matthews K, Steele JD. Predicting methylphenidate response in attention deficit hyperactivity disorder: a preliminary study. J Psychopharmacol. 2015 Jan;29(1):24-30. doi: 10.1177/0269881114548438. Epub 2014 Sep 18.
- Results publication: PubMed 794087Barkley RA. Predicting the response of hyperkinetic children to stimulant drugs: a review. J Abnorm Child Psychol. 1976;4(4):327-48. doi: 10.1007/BF00922531.
- Results publication: PubMed 10385840Chabot RJ, Orgill AA, Crawford G, Harris MJ, Serfontein G. Behavioral and electrophysiologic predictors of treatment response to stimulants in children with attention disorders. J Child Neurol. 1999 Jun;14(6):343-51. doi: 10.1177/088307389901400601.
- Results publication: PubMed 11514638Riccio CA, Waldrop JJ, Reynolds CR, Lowe P. Effects of stimulants on the continuous performance test (CPT): implications for CPT use and interpretation. J Neuropsychiatry Clin Neurosci. 2001 Summer;13(3):326-35. doi: 10.1176/jnp.13.3.326.
- Results publication: PubMed 16890481Sangal RB, Sangal JM. Attention-deficit/hyperactivity disorder: use of cognitive evoked potential (P300) to predict treatment response. Clin Neurophysiol. 2006 Sep;117(9):1996-2006. doi: 10.1016/j.clinph.2006.06.004. Epub 2006 Aug 4.
- Results publication: PubMed 7893855Young ES, Perros P, Price GW, Sadler T. Acute challenge ERP as a prognostic of stimulant therapy outcome in attention-deficit hyperactivity disorder. Biol Psychiatry. 1995 Jan 1;37(1):25-33. doi: 10.1016/0006-3223(94)00075-E.
- Results publication: PubMed 23660970Czerniak SM, Sikoglu EM, King JA, Kennedy DN, Mick E, Frazier J, Moore CM. Areas of the brain modulated by single-dose methylphenidate treatment in youth with ADHD during task-based fMRI: a systematic review. Harv Rev Psychiatry. 2013 May-Jun;21(3):151-62. doi: 10.1097/HRP.0b013e318293749e.
- Results publication: PubMed 21597989Linssen AM, Vuurman EF, Sambeth A, Nave S, Spooren W, Vargas G, Santarelli L, Riedel WJ. Contingent negative variation as a dopaminergic biomarker: evidence from dose-related effects of methylphenidate. Psychopharmacology (Berl). 2011 Dec;218(3):533-42. doi: 10.1007/s00213-011-2345-x. Epub 2011 May 20.
- Derived from this study: PubMed 29940782Ogrim G, Kropotov JD. Predicting Clinical Gains and Side Effects of Stimulant Medication in Pediatric Attention-Deficit/Hyperactivity Disorder by Combining Measures From qEEG and ERPs in a Cued GO/NOGO Task. Clin EEG Neurosci. 2019 Jan;50(1):34-43. doi: 10.1177/1550059418782328. Epub 2018 Jun 25.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Cognitive-Motor Training With the DextEgg in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.
Attention Deficit Hyperactivity Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
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.
Geir Ogrim, PhD principal investigator
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate (MPH) in people with Attention Deficit Hyperactivity Disorder, run by Ostfold Hospital Trust at 1 site 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 1 inclusion and 1 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 1 Mar 2016. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Classification as responders (REs) or non-responders (non-REs) based on daily ratings from parents and teachers of ADHD symptoms during a four weeks medication trial (time frame: Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.). 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 NCT02695355, which also lists 13 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 1 Mar 2016.