Addition of eicosapentaenoic acid to maintenance anti-depressant therapy in diabetes patients with major depressive disorder: a double-blind, placebo-controlled pilot study

ISRCTN	ISRCTN30877831
DOI	https://doi.org/10.1186/ISRCTN30877831
Secondary identifying numbers	DFN 2004.13.004

Submission date: 28/04/2006
Registration date: 28/04/2006
Last edited: 27/02/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr F. Pouwer
Scientific

VU University Medical Center
Department of Medical Psychology
Diabetes Psychology Research Group
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4449679
Email	f.pouwer@vumc.nl

Study information

Study design	Randomised placebo-controlled double blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics approval received from the Medical Ethical Committee of the VU Medical Centre, Amsterdam on the 15th September (ref: METC 2005/137)
Health condition(s) or problem(s) studied	Major depressive disorder
Intervention	Two capsules containing eicosapentaenoic acid (total amount of 1 g/day) or placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Eicosapentaenoic acid
Primary outcome measure	Depression
Secondary outcome measures	Glycaemic control
Overall study start date	01/04/2006
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 BT
Netherlands

Sponsor information

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

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4448180
Email	emgo@vumc.nl
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

Dutch Diabetes Research Foundation (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Dutch Diabetes Research Foundation
Location: Netherlands

Minami Nutrition Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No