Back to resultsEssential Fatty Acids in Adult ADHD (OCEAN-GER)
Primary Purpose
Adult Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Essential fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Adult Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- DSM-IV ADHD
Exclusion Criteria:
- any acute psychiatric disorder
Sites / Locations
- Saarland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Essential fatty acids
Placebo
Arm Description
Omega-3
Placebo tablet
Outcomes
Primary Outcome Measures
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Psychopatholoy of adult ADHD
Secondary Outcome Measures
Short and long interval cortical inhibition (SICI and LICI)
Motoric evoced potentials by transcranial magnetic stimulation (TMS)
Full Information
NCT ID
NCT01798381
First Posted
February 19, 2013
Last Updated
October 27, 2020
Sponsor
Universität des Saarlandes
1. Study Identification
Unique Protocol Identification Number
NCT01798381
Brief Title
Essential Fatty Acids in Adult ADHD
Acronym
OCEAN-GER
Official Title
The Relationship of Essential Fatty Acids to Cognitive, Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Essential fatty acids
Arm Type
Active Comparator
Arm Description
Omega-3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Essential fatty acids
Primary Outcome Measure Information:
Title
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
Description
Psychopatholoy of adult ADHD
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Short and long interval cortical inhibition (SICI and LICI)
Description
Motoric evoced potentials by transcranial magnetic stimulation (TMS)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Cued continous performance test - QB-version
Description
Motorhyper activity, concentration and impulsivity in adult ADHD patients
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
DSM-IV ADHD
Exclusion Criteria:
any acute psychiatric disorder
Facility Information:
Facility Name
Saarland University Hospital
City
Homburg/Saar
State/Province
Saarland
ZIP/Postal Code
D-66421
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Essential Fatty Acids in Adult ADHD
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