Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder
Attention Deficit-Hyperactivity Disorder
About this trial
This is an interventional basic science trial for Attention Deficit-Hyperactivity Disorder focused on measuring Decision-Making, functional MRI, pharmacological MRI, Reinforcement Learning, Methylphenidate
Eligibility 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)
Sites / Locations
- Department of Psychology, University of Oslo
- Adult ADHD diagnostic clinic, Vestre Viken Hospital Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Behavioral
fMRI-arm
Cognitive testing of participants. Asterisk applies for patient group. Day 1: Patient arrives having abstained medication for minimum 20 hours.* Administer either Ritalin or placebo intervention, and wait 60 minutes before computer-testing.* Case Report Form (CRF), ASRS and Wechsler Adult Intelligence Scale (WAIS) subtests. Blood sample, if consented.* Computerized testing. Administer opposite treatment.* Day 2: Patient arrives having abstained medication for a minimum of 20 hours.* Administer either Ritalin or placebo intervention (opposite of Day 1), and wait 60 minutes before computer-testing.* CRF 3, ASRS and Edinburgh Handedness Inventory (EHI). Blood sample, if consented.* Computerized testing. Administer opposite treatment.*
Asterisk applies only for patient group. Day 1: Patient arrives having abstained medication for minimum 20 hours.* Administer either Ritalin or placebo intervention, and wait 60 minutes before MRI testing.* CRF 2, Adult ASRS and WAIS subtests. Blood sample, if consented.* Computerized testing. Administer opposite treatment to ensure the patients have not been withheld from medication for too long while keeping blind.* Day 2 (after 14 - 40 days): Patient arrives having abstained medication for a minimum of 20 hours.* Administer either Ritalin or placebo intervention, and wait 60 minutes before testing (opposite of Day 1).* CRF 3, ASRS and EHI. Blood sample, if consented.* Computerized testing. Administer opposite treatment.*