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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005246-38 | EudraCT Number | ||
| 2012/1105-8 | Other Identifier | Regional Ethics Commitees | |
| 2011/1585-10 | Other Identifier | Regional Ethics Commitees |
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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| The Hospital of Vestfold | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
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The goal of this trial is to investigate the cognitive- and brain-mechanisms underlying decision making (DM) and learning in young adults with Attention-Deficit/Hyperactivity Disorder (ADHD) as well as the modulation of task-related and task-independent brain activation by methylphenidate. The study aims at using a double-blinded, placebo controlled, cross-over, withdrawal design to study the effects of ADHD and methylphenidate in both a behavioural study investigating cognitive effects on decision making and instrumental learning, and a functional MRI (fMRI) study investigating the effects on brain mechanisms during decision making alone. A secondary objective of the trial is to measure the effect of adult ADHD and methylphenidate on cerebral perfusion. This will be done through applying a novel arterial spin labelling MRI-technique on the participants in the fMRI arm of the study.
The immediate scientific goal of this trial is to investigate the cognitive- and brain-mechanisms underlying Decision Making (DM) and instrumental learning in young adults with ADHD as well as the modulation of task-related and task-independent brain activation by MPH. In a more applied perspective, the investigators hope this trial will contribute to the development of tools for improved diagnosis and treatment monitoring of ADHD. Diagnostic tools should be based on the understanding of cognitive and brain mechanisms contributing to the symptom manifestation of ADHD. The study aims at using a double-blinded, placebo controlled cross-over withdrawal design to study the effects of ADHD and MPH in both a behavioural study investigating cognitive effects on DM and instrumental learning, and an fMRI study investigating the effects on brain mechanisms during DM alone. The results of the behavioural DM task from the fMRI experiment will be pooled with the data from the behavioural study to achieve higher statistical power in the analysis of the behavioural data.
A distinctive characteristic of this proposal is to gain insight into differences between ADHD-patients and healthy controls and the effects of methylphenidate (MPH) medication with an approach termed "computational psychiatry" (Maia and Frank, 2011). In this approach, the investigators apply mathematical models of cognition to observed behaviour in order to derive latent decision variables characterizing the DM- and instrumental learning processes. When combined with neuroimaging methods, computational models allow identification of differences in affective and cognitive processes together with the neurobiological processes that underlie these differences (Frank et al., 2004). Such insights should be the foundation of new tools for diagnosis and therapeutic treatment of ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral | Experimental | Cognitive testing of participants. Asterisk applies for patient group. Day 1:
Day 2:
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| fMRI-arm | Experimental | Asterisk applies only for patient group. Day 1:
Day 2 (after 14 - 40 days):
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritalin | Drug | On one of the two test-dates the patient participant is administered methylphenidate, in the dose prescribed by the patients doctor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of ADHD medication on decision making | The study will both use standard statistical models on reaction time and accuracy data, but also use Bayesian Statistics and mathematical modelling. The investigators expect higher Drift Diffusion Model drift rate in the controls and patients on medication, and slower drift rate for participants off medication. | by may 2015 (up to 3 years) |
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Inclusion Criteria:
Drug-Naïve Group
Drug group
Healthy Control Group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats Fredriksen, MD | Vestre Viken Hospital Trust and the University of Oslo | Principal Investigator |
| Guido P Biele, PhD | University of Oslo | Study Director |
| Tor Endestad, PhD | University of Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, University of Oslo | Oslo | Oslo | 0373 | Norway | ||
| Adult ADHD diagnostic clinic, Vestre Viken Hospital Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28861338 | Derived | Mowinckel AM, Alnaes D, Pedersen ML, Ziegler S, Fredriksen M, Kaufmann T, Sonuga-Barke E, Endestad T, Westlye LT, Biele G. Increased default-mode variability is related to reduced task-performance and is evident in adults with ADHD. Neuroimage Clin. 2017 Mar 30;16:369-382. doi: 10.1016/j.nicl.2017.03.008. eCollection 2017. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| C041626 | 5,10-dihydro-5-methylphenazine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | On one of the test-dates the patient participants are administered a sugar pill, matching their prescribes medical dose. |
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| Tønsberg |
| Tønsberg |
| 3103 |
| Norway |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |