Attention deficit hyperactivty disorder MedDRA version: 15.1 Level: PT Classification code 10003736 Term: Attention deficit/hyperactivity disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Ritalin
Product Name: Ritalin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Ritalin
Product Name: Rit
Sponsors
University of Oslo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The prospective patient participants at screening prior to receiving study agent must meet all of the following conditions: • 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. One subgroup of the study will be drug-naïve ADHD patients, before they start medical treatment (newly diagnosed and awaiting approval from cardiologist to start drug treatment). After medication start, these patients will be recruited to continue the experiment as the other participants. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with the following groups of pharmacological agents will be considered as exclusion criteria for participation: • Antidepressants (MOA-inhibitors, Tricyclic antidepressants, SSRIs) • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of methylphenidate on behavioural processes and brain mechanisms involved in decision making and instrumental in adults with ADHD. We will be testing patients on and off their already prescribed medication dose while they are performing a value-based decision making task and/or an instrumental learning task, either in an MRI-scanner (to document the effects of methylphenidate on decision making and the brain processes associated with this) or without MRI in a pure behavioural arm.;Secondary Objective: To evaluate the effect of methylphenidate on cerebral perfusion in adult ADHD, measured by an Arterial Spin Labeling MRI-technique. This part of the study will also investigate drug-naïve patients before medication start-up. ;Primary end point(s): 1)Attention to negative outcomes, measured as the impact of the cost-dimension of options on choice behaviour in the cost/benefit DM-task (CBDM, Basten et al. 2010). 2)Impulsiveness, measured as consistency of choosing and reaction times in the CBDM. 3)Memory of recent outcomes, measured as the learning rate of a reinforcement learning model fitted to participants behaviour (Yachiam at al, 2005). 4)Erratic choosing, measured as the sensitivity parameter of the choice rule in the reinforcement learning model (Yechiam et al, 2005). 5)Reliability of the neural gain- and loss-signals, measured as the correlation between the magnitude of gain- and loss-values in the options presented in the CBDM-task and the BOLD-response in the ventral striatum (gains) and the amygdala (losses), respectively. 6)Integration of gains and losses into a neural decision signal, measured as correlation of the the difference of the neural loss signal in the amygdala and the neural gain signal in the nucleus accumbens with the BOLD response in the VMPFC (Basten et al, 2010). 7)Predictive power of change in the latent parameters of DM and instrumental learning described in 1-4 after single-dose MPH-challenge for | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 8) Cerebral blood flow (CBF) in the dopaminergic mesolimbic system, as measured by arterial spin labeling (ASL) MRI. 9) Predictive power of change in CBF-measurements after single-dose MPH-challenge for the clinical efficacy of MPH in specific patients.;Timepoint(s) of evaluation of this end point: Each participant will be scanned twice, once on and once off medication. Drug-naïve participants will be scanned three times: first as drug-naïve and then included in the regular trial course and scanned on and off medication after achieving stable treatment. Effect of disease and medication will be checked after completion of all testing sessions for each participant. Statistical significance testing will be done after all last visit of last participant. | — |
Countries
Norway
Contacts
Public ContactGuido Biele
University of Oslo
Outcome results
None listed