Essential Fatty Acids in Adult ADHD (OCEAN-GER)

October 27, 2020 updated by: Michael Rösler, Universität des Saarlandes

The Relationship of Essential Fatty Acids to Cognitive, Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls

The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg/Saar, Saarland, Germany, D-66421
        • Saarland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV ADHD

Exclusion Criteria:

  • any acute psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablet
Dietary supplement: Essential fatty acids
Active Comparator: Essential fatty acids
Omega-3
Dietary supplement: Essential fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Time Frame: 6 months
Psychopatholoy of adult ADHD
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short and long interval cortical inhibition (SICI and LICI)
Time Frame: 6 months
Motoric evoced potentials by transcranial magnetic stimulation (TMS)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cued continous performance test - QB-version
Time Frame: 6 months
Motorhyper activity, concentration and impulsivity in adult ADHD patients
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität des Saarlandes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCEAN-GER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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