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Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder

Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01831622
Enrollment
131
Registered
2013-04-15
Start date
2013-06-30
Completion date
2015-06-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit-Hyperactivity Disorder

Keywords

Decision-Making, functional MRI, pharmacological MRI, Reinforcement Learning, Methylphenidate

Brief summary

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.

Detailed description

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.

Interventions

On one of the two test-dates the patient participant is administered methylphenidate, in the dose prescribed by the patients doctor.

DRUGPlacebo

On one of the test-dates the patient participants are administered a sugar pill, matching their prescribes medical dose.

Sponsors

The Research Council of Norway
CollaboratorOTHER
The Hospital of Vestfold
CollaboratorOTHER
Norwegian Institute of Public Health
CollaboratorOTHER_GOV
Mats Fredriksen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Drug-Naïve Group * Comply with Diagnostic and Statistical Manual (DSM) -IV criteria for ADHD. * No history of medication with Methylphenidate. * Must be between the age of 18 and 40. * Signed informed consent and expected cooperation of the patients for the intervention and the test dates must be obtained and documented according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and national/local regulations. * After stable medication is established, these will be incorporated into the study following the procedures of the drug group. Drug group * Comply with DSM-IV criteria for ADHD. * On stable treatment with MPH. * Must be between the age of 18 and 40. * Signed informed consent and expected cooperation of the patients for the intervention and the test dates must be obtained and documented according to ICH GCP, and national/local regulations. Healthy Control Group * Must be between the age of 18 and 40. * No current psychiatric diagnosis. * Signed informed consent and expected cooperation of the patients for the intervention and the test dates must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion criteria

* Treatment with the following groups of pharmacological agents will be considered as

Design outcomes

Primary

MeasureTime frameDescription
Effect of ADHD medication on decision makingby may 2015 (up to 3 years)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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026