Status:
COMPLETED
Influence of Stimulant Medication on Brain Processes for Decision Making in Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Mats Fredriksen
Collaborating Sponsors:
The Research Council of Norway
The Hospital of Vestfold
Conditions:
Attention Deficit-Hyperactivity Disorder
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
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 a...
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 mod...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01831622
Start Date
June 1 2013
End Date
June 1 2015
Last Update
December 2 2015
Active Locations (2)
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1
Department of Psychology, University of Oslo
Oslo, Oslo County, Norway, 0373
2
Adult ADHD diagnostic clinic, Vestre Viken Hospital Trust
Tønsberg, Tønsberg, Norway, 3103