Completed

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

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What is being tested

Essential fatty acids

+ Essential fatty acids

Dietary Supplement
Who is being recruted

Mental Disorders+1

+ Attention Deficit and Disruptive Behavior Disorders

+ Neurodevelopmental Disorders

From 18 to 60 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversität des Saarlandes
Last updated: October 29, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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).

NCT01798381
Principal SponsorUniversität des Saarlandes
Last updated: October 29, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAttention Deficit Disorder with Hyperactivity

Criteria

1 inclusion criteria required to participate
DSM-IV ADHD
1 exclusion criteria prevent from participating
any acute psychiatric disorder

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Omega-3

Group II

Placebo
Placebo tablet

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Saarland University Hospital

Homburg/Saar, GermanyOpen Saarland University Hospital in Google Maps
CompletedOne Study Center