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Essential Fatty Acids in Adult ADHD (OCEAN-GER)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Michael Rösler, Saarland University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798381
First Posted: February 25, 2013
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Rösler, Saarland University
  Purpose
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 Intervention Phase
Adult Attention Deficit Hyperactivity Disorder Dietary Supplement: Essential fatty acids Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael Rösler, Saarland University:

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

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


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

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Essential fatty acids
Omega-3
Dietary Supplement: Essential fatty acids
Placebo Comparator: Placebo

  Eligibility

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
Criteria

Inclusion Criteria:

  • DSM-IV ADHD

Exclusion Criteria:

  • any acute psychiatric disorder
  Contacts and Locations
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


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

Locations
Germany
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
  More Information

Responsible Party: Michael Rösler, Prof. Dr., Saarland University
ClinicalTrials.gov Identifier: NCT01798381     History of Changes
Other Study ID Numbers: OCEAN-GER
First Submitted: February 19, 2013
First Posted: February 25, 2013
Last Update Posted: February 25, 2013
Last Verified: February 2013

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