NCT01798381

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

February 19, 2013

Last Update Submit

October 27, 2020

Conditions

Adult Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)

    Psychopatholoy of adult ADHD

    6 months

Secondary Outcomes (1)

  • Short and long interval cortical inhibition (SICI and LICI)

    6 months

Other Outcomes (1)

  • Cued continous performance test - QB-version

    6 months

Study Arms (2)

Essential fatty acids

ACTIVE COMPARATOR

Omega-3

Dietary Supplement: Essential fatty acids

Placebo

PLACEBO COMPARATOR

Placebo tablet

Dietary Supplement: Essential fatty acids

Interventions

Essential fatty acidsDIETARY_SUPPLEMENT
Essential fatty acidsPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV ADHD

You may not qualify if:

  • any acute psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Hospital

Homburg/Saar, Saarland, D-66421, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Fatty Acids, Essential

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, UnsaturatedFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 25, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

October 29, 2020

Record last verified: 2020-10

Locations

DE(1)