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 |
| Protocol serial number | DFN 2004.13.004 |
| Sponsor | VU University Medical Center, EMGO-Institute (The Netherlands) |
| Funders | Dutch Diabetes Research Foundation (The Netherlands), Minami Nutrition Inc. (USA) |
- 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
Contact information
Dr F. Pouwer
Scientific
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 |
|---|---|
| f.pouwer@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled double blind trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Eicosapentaenoic acid |
| Primary outcome measure(s) |
Depression |
| Key secondary outcome measure(s) |
Glycaemic control |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
