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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mats Fredriksen
• Collaborators: Norwegian Institute of Public Health; The Hospital of Vestfold; The Research Council of Norway
• Treatments: Central Nervous System Stimulants; Methylphenidate

Criteria

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 exclusion criteria for participation:

• Antidepressants (MOA-inhibitors, Tricyclic antidepressants, Selective Serotonin Re-uptake Inhibitors)

• Antipsychotics (both first and second generation)

• Anxiolytics/hypnotics (benzodiazepines, barbiturates)

• Opiates

• History of alcohol or drug abuse.

• History of moderate to severe head injury.

• Major psychiatric comorbidity (i.e. psychosis, active suicidal ideation or acute exacerbation of other psychiatric condition in need of immediate treatment).

• Epilepsy

• History of severe memory loss

• Under treatment for metabolic disorders

• Severe primary sensory loss

• Any condition contraindicating treatment with methylphenidate will automatically lead to exclusion, since these patients will not receive methylphenidate from clinician and thus will not meet inclusion criteria (including pregnancy, methylphenidate allergies, incompatible concomitant medication etc.).

• MRI specific criteria: contraindications for MRI (i.e. metallic or circuit-containing implants, severe claustrophobia)