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Essential Fatty Acids in Adult ADHD (OCEAN-GER)

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ClinicalTrials.gov Identifier: NCT01798381
Recruitment Status : Unknown
Verified February 2013 by Michael Rösler, Saarland University.
Recruitment status was:  Recruiting
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Information provided by (Responsible Party):
Michael Rösler, Saarland University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Adult Attention Deficit Hyperactivity Disorder Dietary Supplement: Essential fatty acids Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Relationship of Essential Fatty Acids to Cognitive, Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
Study Start Date : December 2012
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Essential fatty acids
Dietary Supplement: Essential fatty acids
Placebo Comparator: Placebo

Primary Outcome Measures :
  1. Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Short and long interval cortical inhibition (SICI and LICI) [ Time Frame: 6 months ]
    Motoric evoced potentials by transcranial magnetic stimulation (TMS)

Other Outcome Measures:
  1. Cued continous performance test - QB-version [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


Exclusion Criteria:

  • any acute psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798381

Contact: Michael Rösler, Professor +49 6841 162 6350 michael.roesler@uks.eu

Saarland University Hospital Recruiting
Homburg/Saar, Saarland, Germany, D-66421
Contact: Michael Rösler, Professor       michael.roesler@uks.eu   
Principal Investigator: Michael Rösler, Professor         
Sponsors and Collaborators
Saarland University

Responsible Party: Michael Rösler, Prof. Dr., Saarland University
ClinicalTrials.gov Identifier: NCT01798381     History of Changes
Other Study ID Numbers: OCEAN-GER
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms