Essential Fatty Acids in Adult ADHD (OCEAN-GER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Saarland University
Sponsor:
Information provided by (Responsible Party):
Michael Rösler, Saarland University
ClinicalTrials.gov Identifier:
NCT01798381
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Saarland University:

Primary Outcome Measures:
  • Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short and long interval cortical inhibition (SICI and LICI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Motoric evoced potentials by transcranial magnetic stimulation (TMS)


Other Outcome Measures:
  • Cued continous performance test - QB-version [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DSM-IV ADHD

Exclusion Criteria:

  • any acute psychiatric disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michael Rösler, Prof. Dr., Saarland University
ClinicalTrials.gov Identifier: NCT01798381     History of Changes
Other Study ID Numbers: OCEAN-GER
Study First Received: February 19, 2013
Last Updated: February 21, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 14, 2014