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

NCT03661788 | Completed Phase 4 DMC

• 2 other identifiers: 11-185 CAIAC2013-002386-18
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atomoxetin; fMRT

Outcome Measures

Primary Outcomes (1)

• FMRT resting state connecitivty of the default mode network

  4 weeks

Study Arms (2)

First placebo, than atomoxetin

EXPERIMENTAL

Patients receive a placebo in the first of the two 14-day treatment intervals and atomoxetin in the second 14-day treatment intervals. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized.

Drug: Atomoxetine; Drug: Placebos

First atomoxetin, than placebo

EXPERIMENTAL

Patients receive atomoxetin in the first of the two 14-day treatment intervals and a placebo in the second 14-day treatment interval. Between the treatment intervals there is a wash-out phase of two weeks. The order of treatment is randomized.

Drug: Atomoxetine; Drug: Placebos

Interventions

Atomoxetine DRUG

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

Also known as: Strattera

First atomoxetin, than placebo; First placebo, than atomoxetin

Placebos DRUG

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

First atomoxetin, than placebo; First placebo, than atomoxetin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male Age 18-45 years Diagnosis of ADHD (patients) or no axis I disorder (controls) according the DSM IV No substance abuse/ dependency Understanding of the study information and declaration of agreement Ability to read, understand and speak German No severe medical disorders No risk for suicide

You may not qualify if:

• Drug dependence or the a positive drug screening Other Severe physical disorders Current pharmacological therapy because of another psychiatric disorder Risk for seizure or cardiac problems Impaired liver and renal function Significant deviations in regard to clinical chemistry, haematology or EKG Relationship of dependency with the sponsor or the investigator Unable to keep to the study protocol Known Intolerance of the study medication fMRI scanner incompatibility

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: May 1, 2016
• Primary Completion: December 6, 2017
• Study Completion: June 27, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)