NCT02578342

Brief Summary

The aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against ADHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

4.8 years

First QC Date

August 3, 2015

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in blood oxygenation level dependency (BOLD)

    The study consist solely of one MRI examination performed within 2 hours.

    2 hours

Study Arms (3)

Healthy volunteers

healthy volunteer between age of 20 to 55 will undergo MRI examination.

Device: MRI

ADHD subjects without medication

Medication-naive subjects with ADHD (20-55 years) will undergo MRI examination.

Device: MRI

ADHD subjects with medication

Subjects with ADHD (20-55 years), under medication will undergo MRI examination.

Device: MRI

Interventions

MRIDEVICE

Functional Magnetic Resonance Imaging technique measures brain activity by detecting associated changes in blood oxygenation level dependency

ADHD subjects with medicationADHD subjects without medicationHealthy volunteers

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Three groups: 1. healthy volunteers 2. ADHD subjects receiving medications 3. medication-naive ADHD subjects

You may qualify if:

  • Participant is between 20-55 years old
  • Participant is not pregnant

You may not qualify if:

  • Participant is not able to consent him/herself
  • Suspected or proven pregnancy
  • Nursing
  • Neurological diseases that could interfere with a diagnosis of ADHD
  • Psychiatric comorbidity under treatment
  • Previous history of psychiatric medication
  • Substance abuse
  • Intelligence quotient\<75
  • Claustrophobia
  • Electrical simulator nerve or bone
  • Implanted medication infusion pump
  • Cerebral aneurysm clips
  • Unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

Related Publications (1)

  • Berberat J, Huggenberger R, Montali M, Gruber P, Pircher A, Lovblad KO, Killer HE, Remonda L. Brain activation patterns in medicated versus medication-naive adults with attention-deficit hyperactivity disorder during fMRI tasks of motor inhibition and cognitive switching. BMC Med Imaging. 2021 Mar 19;21(1):53. doi: 10.1186/s12880-021-00579-3.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 3, 2015

First Posted

October 16, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2020

Study Completion

November 1, 2020

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations