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

NCT01831622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

  • Attention Deficit-Hyperactivity Disorder

Interventions

DRUG

Ritalin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER
  • The Hospital of Vestfold

    collaborator OTHER
  • Norwegian Institute of Public Health

    collaborator OTHER_GOV
  • Mats Fredriksen

    lead OTHER

Principal Investigators

  • Mats Fredriksen, MD · Vestre Viken Hospital Trust and the University of Oslo

  • Guido P Biele, PhD · University of Oslo

  • Tor Endestad, PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831622 on ClinicalTrials.gov