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Essential Fatty Acids in Adult ADHD (OCEAN-GER)

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.
 
ClinicalTrials.gov Identifier: NCT01798381
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Rösler, Universität des Saarlandes

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Essential fatty acids
Omega-3
 Dietary Supplement: Essential fatty acids
Placebo Comparator: Placebo
Placebo tablet
 Dietary Supplement: Essential fatty acids


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


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 ]
    Motorhyper activity, concentration and impulsivity in adult ADHD patients


Eligibility Criteria
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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
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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


Locations
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Germany
Saarland University Hospital
Homburg/Saar, Saarland, Germany, D-66421
Sponsors and Collaborators
Universität des Saarlandes
More Information
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Responsible Party: Michael Rösler, Prof. Dr., Universität des Saarlandes
ClinicalTrials.gov Identifier: NCT01798381    
Other Study ID Numbers: OCEAN-GER
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases