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Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD

NCT03661788 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-09-07

No results posted yet for this study

Summary

Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood but often persists through adulthood. The most prominent symptoms in adults are inattention, emotional instability, disorganized behavior, impulsivity and restlessness, which cause several restrictions in different areas of life. It is suggested that those symptoms can be attributed to a general deficit in inhibitory control. This hypothesis is supported by several studies revealing that patients with ADHD show poor performance completing inhibitory control tasks.

Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly improves inhibitory control in patients with ADHD as well as in healthy participtants. In contrast to other medication authorized for the treatment of patients with ADHD, does ATX has no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.

Although we directly often associate failures in cognitive control with disruptions at prefrontal areas of the brain, there exists a specific brain network which is called the default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD symptomatic.

The following study is interested in which way a 2- week intake of ATX affects the DMN and surrounding networks in their connectivity during a inhibitory control task and during rest in patients with ADHD vs controls.

Conditions

  • ADHD

Interventions

DRUG

Atomoxetine

14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills)

DRUG

Placebos

14-day treatment interval: first week one placebo pill, second week two placebo pills

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-12-06
Completion
2018-06-27

Countries

  • Germany

Study Locations

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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 NCT03661788 on ClinicalTrials.gov