Essential Fatty Acids in Adult ADHD | NCT01798381

Studies
Essential Fatty Acids in Adult ADHD

NCT01798381

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Oct 29, 2020Actual

Enrollment

100Actual

Phase

Phase 3

Conditions

Adult Attention Deficit Hyperactivity Disorder

Interventions

Essential fatty acids

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 19, 2013

First Submission Date that Met QC Criteria

Feb 21, 2013

First Posted Date

Feb 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2020

Last Update Posted Date

Oct 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Essential fatty acids	Active Comparator	Omega-3	Dietary Supplement: Essential fatty acids
Placebo	Placebo Comparator	Placebo tablet	Dietary Supplement: Essential fatty acids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Essential fatty acids	Dietary Supplement		Essential fatty acids Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)	Psychopatholoy of adult ADHD	6 months

Secondary Outcomes

Measure	Description	Time Frame
Short and long interval cortical inhibition (SICI and LICI)	Motoric evoced potentials by transcranial magnetic stimulation (TMS)	6 months

Other Outcomes

Measure	Description	Time Frame
Cued continous performance test - QB-version	Motorhyper activity, concentration and impulsivity in adult ADHD patients	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV ADHD

Exclusion Criteria:

any acute psychiatric disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saarland University Hospital		Homburg/Saar	Saarland	D-66421	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005228	Fatty Acids, Essential

Ancestor Terms

ID	Term
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided