Condition category
Mental and Behavioural Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
27/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.diabetespsychology.nl/abstracts/omega-3.htm

Contact information

Type

Scientific

Primary contact

Dr F. Pouwer

ORCID ID

Contact details

VU University Medical Center
Department of Medical Psychology
Diabetes Psychology Research Group
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4449679
f.pouwer@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DFN 2004.13.004

Study information

Scientific title

Acronym

Study hypothesis

Addition of eicosapentaenoic acid (1 g/day) to maintenance anti-depressant therapy in diabetes patients with major depression will be associated with a reduction of depression symptoms, compared to placebo (1 g grapeseed oils).

Ethics approval

Ethics approval received from the Medical Ethical Committee of the VU Medical Centre, Amsterdam on the 15th September (ref: METC 2005/137)

Study design

Randomised placebo-controlled double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major depressive disorder

Intervention

Two capsules containing eicosapentaenoic acid (total amount of 1 g/day) or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Eicosapentaenoic acid

Primary outcome measures

Depression

Secondary outcome measures

Glycaemic control

Overall trial start date

01/04/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 - 75 years old
2. Having diabetes
3. Current diagnosis of major depressive disorder that is being treated with ongoing anti-depressant medication
4. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Psychotic features
2. History of (hypo)-mania
3. An average consumption of fish higher than two servings per week or current daily use of fish oil supplements
4. Active suicidal ideation or a history of suicide attempt
5. Allergy for fish or fish products
6. Pregnancy

Recruitment start date

01/04/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Center, EMGO-Institute (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448180
emgo@vumc.nl

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Dutch Diabetes Research Foundation (The Netherlands)

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Minami Nutrition Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23209576

Publication citations

  1. Results

    Mocking RJ, Assies J, Bot M, Jansen EH, Schene AH, Pouwer F, Biological effects of add-on eicosapentaenoic acid supplementation in diabetes mellitus and co-morbid depression: a randomized controlled trial., PLoS ONE, 2012, 7, 11, e49431, doi: 10.1371/journal.pone.0049431.

Additional files

Editorial Notes